Name of study
Type of study
Intervention
Outcome measures
Result
Almeyda et al. [9]
Randomized, double-blind, paired-comparison trial
10% urea and 1% hydrocortisone vs cream 0.1% betamethasone 17-valerate cream applied twice daily for 3 weeks
Lesion response: excellent, good, none, deterioration
I% hydrocortisone controls atopic eczema without the hazards of potent fluorinated corticosteroids and it is as effective as 0.1% betamethasone 17-valerate
Andersen et al. [10]
Randomized, double-blind, left–right multicentre study
Mildison lipocream 1% hydrocortisone ointment twice daily vs Uniderm cream 1% hydrocortisone ointment twice daily
Global severity of symptoms, global improvement of skin lesions, investigator and patient preference
Little efficacy difference between treatments, yet patients preferred the Mildison lipocream 1% hydrocortisone ointment
Bagatell et al. [11]
Double-blind, randomized and balanced-parallel-group trial
Alclometasone dipropionate cream 0.05% vs hydrocortisone cream 1.0% thrice daily for 3 weeks
Erythema, induration, pruritus Investigator global evaluation
71% alclometasone patients showed marked improvement compared to 69% hydrocortisone patients
Beattie et al. [12]
Randomized, single-observer trial
Hydrocortisone 1% once daily vs Hydrocortisone 1% twice daily. Both groups were instructed to apply emollient as and when required
Six Area, Six Sign Atopic Dermatitis (SASSAD) severity score, Infants Dermatology Quality of Life Index (IDQOL), Dermatitis Family Impact (DFI) and Side effects
conventional therapy with hydrocortisone and emollients alone is as effective as wet-wrap therapy for infants with moderately severe, widespread AD
Binder et al. [13]
Randomized, double-blind, paired-comparison trial
Fluocinonide 0.05% cream twice daily vs Betamethasone valerate 0.01% cream twice daily for 2 weeks
Lesion improvement
Fluocinolone was superior to betamethasone in 70% of patients but difficult to interpret magnitude of effect
Bleehen et al. [14]
Randomized, double-blind, parallel-group controlled trial
Fluticasone propionate 0.05% cream OD vs Fluticasone propionate 0.05% cream BD for 4 weeks
Patient diary cards for itch, rash and sleep disturbance and physician assessed six signs and global assessment
Improvement within first week in 80% patients in o.d. vs 85% in b.d. groups but method and concealment of randomization was unclear
Bleeker et al. [15]
Randomized, double-blind trial
halcinonide 0.1% cream twice daily vs clobetasol propionate 0.05% cream twice daily for 2 weeks
Decrease in erythema, oedema, transudation, lichenification, scaling, pruritus and pain
92% ‘excellent’ or ‘good’ clinical response for both groups
Duke et al. [16]
Randomized, parallel-group design, blind evaluator study
Alclometasone dipropionate 0.05% ointment bd vs clobetasone butyrate 0.05% ointment bd for 3 weeks
Clinical score erythema, induration, pruritus, and physician global assessment
75% improvement in alclometasone group compared with 68% improvement in clobetasone group
Fisher et al. [17]
Randomized, double-blind, left-right comparison trial
Fluocinonide 0.05% cream tds vs Betamethasone valerate 0.1% cream tds for 3 weeks
Clinical response relative to status of lesion
Mean clinical response better in fluocinonide than betamethasone on a scale of 1–5
Foelster-Holst et al. [18]
Randomized controlled trial
Topical corticosteroid prednicarbate with vs without partial wet-wrap dressing
Local SCORAD
Wet-wrap therapy with a topical corticosteroid is an effective treatment option in patients with exacerbated AD
Glazenburg et al. [19]
Randomized, double-blind, controlled trial
Placebo ointment bd vs fluticasone propionate 0.005% ointment bd for 16 weeks
SCORAD
Addition of twice-weekly FP to standard maintenance therapy significantly reduces the risk of relapse in children with moderate severe AD
Grimalt et al.a [5]
Open randomized controlled study
Micronized desonide 0.1% cream Locatop and/or desonide 0.1% cream Locapred with vs without emollient (Exomega)
Scoring Atopic Dermatitis Index (SCORAD), and infants’ and parents’ quality of life by Infant’s Dermatitis Quality of Life Index and Dermatitis Family Impact scores
Emollients significantly reduced the high-potency topical corticosteroid consumption in infants with AD
Haneke et al. [20]
Randomized, double-blind, left–right comparison trial
0.1% methylprednisolone aceponate ointment o.d vs 0.1% betamethasone valerate b.d. for 4 weeks
Patient and doctor global assessments
Actual data not found and method and concealment of randomization not clear
Hanifin et al. [21]
Randomized, investigator-blind, left–right comparison trial
desonide 0.05% lotion bd vs desonide 0.05% lotion bd plus a moisturizing cream tds for 4 weeks
erythema, dryness or scaling, pruritus, excoriations, lichenification, oozing or crusting, and induration or papules
Addition of a moisturizer to a low-potency corticosteroid lotion was effective in treating mild-to-moderate atopic dermatitis
Hanifin et al. [22]
Randomized, double-blind parallel trial
Intermittent fluticasone propionate or vehicle, once daily 4 days per week for 4 weeks followed by once daily 2 days per week for 16 weeks
Global assessment score
Once stabilized with fluticasone treatment, the risk of relapse significantly reduced by extended intermittent dosing with fluticasone cream in addition to regular emollient therapy
Haribhakti et al. [23]
Randomized, double-blind, controlled trial
Clobetasone butyrate cream bd vs Hydrocortisone cream bd for 2–3 weeks
erythema, dryness or scaling, pruritus, excoriations, lichenification, oozing or crusting
Reductions in pre-treatment total scores have been greater for Clobetasone as compared to hydrocortisone, the difference becoming significant at the end of 3 weeks of treatment
Hebert et al. [24]
Multicentre, randomized, blinded, vehicle-controlled studies
desonide hydrogel 0.05% bd vs hydrogel vehicle bd for 4 weeks
SCORAD
Desonide hydrogel 0.05% was extremely well tolerated and provided statistically significant improvements in all primary (P < 0.001) and secondary (P < 0.006) efficacy endpoints in both studies
Hoybye et al. [25]
Randomized, single-blind, parallel-group and multicentre trial
Mometasone furoate cream o.d. vs hydrocortisone 17-butyrate cream b.d. for 6 weeks
Patient VAS for severity of eczema, 0–3 score for doctor-assessed erythema, infiltration and pruritus, global evaluation scores of 1–6
No difference in efficacy between the two treatments
Jorizzo et al. [26]
Randomized, investigator-masked, parallel-group design trial
Desonide 0.05% ointment vs hydrocortisone 1% ointment b.d. for 5 weeks
Physician global improvement, erythema, lichenification excoriations, oozing and crusting, induration and papules Pruritus assessed subjectively
68% desonide group and 40% hydrocortisone group had marked improvement at 5 weeks
Kirkup et al. [27]
Multicentre, randomized, double-blind, parallel-group trial
One study compared FP with hydrocortisone (HC) 1% cream (FP 70, HC 67) and the other with hydrocortisone butyrate (HCB) 0.1% cream (FP 67, HCB 62). Treatments were applied twice daily, for 2–4 weeks until the AD was stabilized, and thereafter intermittently (‘as required’) for up to 12 weeks
Pruritus, erythema, scaling, lichenification, oozing, excoriation, overall global impression
FP demonstrated a high level of efficacy and maintenance of disease control with a tolerability similar to HC 1%
Koopmans et al. [28]
Randomized, double-blind, controlled trial
0.1% hydrocortisone 17-butyrate cream b.d. vs o.d. plus vehicle o.d. for 4 weeks
Patient and doctor assessed overall severity Clinical features assessed were erythema, induration, pruritus and excoriation
78% o.d. vs 93% b.d. noticed considerable improvement
Korting et al. [29]
Randomized, double-blind, left–right comparison trial
0.039% liposomal betamethasone dipropionate vs 0.054% commercial propylene glycol gel for 2 weeks
Investigator assessed ten signs and symptoms of eczema and proportion of patients with major improvement or healed and global effect on a 0–5 scale
80% patients had major improvement in liposome group compared with 60% patients in reference group
Lassus et al. [30]
Randomized double-blind, parallel-group trial
Alclometasone dipropionate cream 0.05% b.d. vs hydrocortisone butyrate cream 0.1% b.d. for 2 weeks
Erythema, induration, pruritus Physician global evaluation of improvement
76–100% marked improvement in 40% of alclometasone patients and 35% of hydrocortisone patients
Lebwohl et al. [31]
Randomized, evaluator-blind, parallel-group trial
0.1% mometasone furoate cream o.d. vs 0.2% hydrocortisone valerate cream b.d. for 3 weeks
Investigator assessed seven signs and symptoms on a 0–3 scale (0 = none, 3 = severe) and global assessment % improved
Mean improvement in severity score (no baselines given) at day 21 (% of patients with 100% clearance), 87.4% for mometasone and 79.7% for hydrocortisone valerate at Day 21
Lucky et al. [32]
Single-centre, randomized, parallel, open-label study
Desonide 0.05% ointment vs hydrocortisone 2.5% ointment b.d. for 4 weeks
Hypothalamic pituitary–adrenal (HPA) axis (cortisol levels)
−1.6 and −1.3% change in cortisol levels over baseline at 4 weeks for desonide and hydrocortisone groups, respectively
Marchesi et al. [33]
Randomized, third-party blind evaluator, parallel-group controlled trial
Mometasone furoate ointment 0.1% o.d. vs betamethasone dipropionate ointment 0.05% b.d. for 3 weeks
Investigator assessed erythema, induration and pruritus on a 0–3 scale, global evaluation % improvement
100% patients in both groups had experienced good improvement by week 3
Morley et al. [34]
Randomized, double-blind controlled trial
0.05% clobetasone butyrate cream or ointment b.d. vs 0.et al.% flurandrenolone cream or ointment b.d. for 1 week
Clinician-assessed lesions as healed, improved, static or worse plus clinician/patient preference for right/left side
Data to assess effect of treatment absent
Msika et al. [35]
Randomized controlled trial
Corticosteroids with or without a new emollient cream
SCORAD and quality of life index
Twice-daily application of a new natural emollient proved to be a major steroid sparing alternative, improved the lichenification and excoriation and also, it improved the quality of life in children and their parents
Olholm Larsen et al. [36]
Randomized controlled trial
Mildison lipocream (1% hydrocortisone in 65/35% oil-in-water emulsion) bd vs Uniderm cream (1% hydrocortisone cream) b.d. for 4 weeks
SCORAD
Significant improvement in both groups
Oliveira et al. [37]
Randomized, double-blind, comparative trial
Mometasone furate 0.1% cream bd vs Desonide 0.5% cream o.d.
SCORAD and quality of life index
Significantly better outcome in mometasone group
Pei et al. [38]
Randomized, single-blind, controlled trial
wet-wrap dressings with 0.1% mometasone furoate and 0.005% fluticasone propionate ointments
SCORAD and global assessment score
Both were effective in the treatment of atopic dermatitis, and that wet wraps are useful in further improving refractory disease in children
Peserico et al. [39]
Double-blind, placebo-controlled, randomized, parallel-group study
Emollient with or without methylprednisolone aceponate (MPA) 0.1% cream twice weekly
Time to relapse, relapse rate and disease status, the patient’s assessment of intensity of itch, the Eczema Area and Severity Index, the IGA score, affected body surface area, Dermatology Life Quality Index (DLQI) and children’s DLQI (CDLQI), patient’s and investigator’s global assessment of response and patient’s assessment of quality of sleep
MPA twice weekly plus an emollient provides an effective maintenance treatment regimen to control AD
Rafanelli et al. [40]
Randomized, third-party blind parallel-group trial
0.1% Mometasone furoate cream od vs 0.05% Clobetasone cream bd for 3 weeks
Pruritus, erythema and DLQI
Mometasone cream was very effective
Rajka et al. [41]
Randomized, double-blind, left–right comparison trial
Hydrocortisone 17-butyrate (Locid®) 0.1% fatty cream bd vs Desonide (Apolar®) 0.1% ointment bd for 4 weeks
Investigator assessed global severity and severity grades of erythema, induration and scaling
Mean global severity score over baseline of 2.8 reduced to 1.3 for hydrocortisone and 1.7 for desonide
Rampini et al. [42]
Randomized, double-blind trial
Methylprednisolone aceponate 0.1% cream b.d. vs prednicarbate 0.25% cream b.d.
Objective and subjective symptoms of erythema, exudation, scaling, hyperkeratosis, itching, burning Global therapeutic response
100% prednicarbate patients showed complete clearing compared to 97.3% of other group
Rampini et al. [42]
Randomized, double-blind trial
Methylprednisolone aceponate 0.1% o.d. ointment vs prednicarbate 0.25% cream b.d.
Objective and subjective symptoms of erythema, exudation, scaling, hyperkeratosis, itching, burning Global therapeutic response
98.1% prednicarbate patients showed complete clearing compared to 96.3% of other group
Reidhav et al. [43]
Randomized, double-blind controlled trial
Betamethasone valerate 0.1% cream od vs mometasone furoate 0.1% cream od for 4 weeks
Patient assessed pruritus and smarting pain on 0–3 scale, evaluator assessed erythema, scaling, lichenification, excoriation, papules, and vesicles
Both showed good improvement without any significant difference
Richelli et al. [44]
Randomized parallel trial
Clobetasone 17-butyrate lotion b.d. (8 am and 3 pm) vs b.d. (3 pm and 8 pm) or o.d. (9 pm) for 3 weeks
Itching, burning, pain, erythema, oedema, exudation, blisters, bullae, scabs, scaling, lichenification, pooled into a mean score Serum cortisol and ACTH tests
No obvious differences between three groups
Rubio et al. [45]
Randomized controlled, double-blind trial
fluticasone propionate cream 0.05% bd vs vehicle cream bd for 16 weeks
Pruritus, erythema, scaling, excoriation, lichenification
Excellent improvement with fluticasone
Ruzicka et al. [46]
Randomized, double-blind controlled trial
mometasone furoate with a water content of 33% (Monovo® Cream) and with a smooth consistency versus the commercially available fatty cream of mometasone furoate (Ecural® Fettcreme)
efficacy, cosmetic properties, and patients’ acceptance
new formulation was preferred by the patients
Savin et al. [47]
Randomized, double-blind controlled trial
Betamethasone dipropionate ointment 0.05% vs hydrocortisone ointment 1% b.d. for 3 weeks
Clinical effectiveness: excellent(>75%), good (50–75%), fair (25–50%), poor (<25%)
50% betamethasone ‘excellent’ or ‘good’ response compared with 22% hydrocortisone
Thomas et al. [48]
Randomized, double-blind, parallel clinical trial
1% hydrocortisone ointment bd vs 0.1% betamethasone valerate ointment bd for 3 days followed by white soft paraffin for four days
Scratch-free days, number of relapses, median duration of relapses, number of undisturbed nights, disease severity (six area, six sign atopic dermatitis severity scale), scores on two quality of life measures (children’s life quality index and dermatitis family impact questionnaire), and number of patients in whom treatment failed in each arm
short burst of a potent topical corticosteroid is just as effective as prolonged use of a milder preparation
Torok et al. [49]
Investigator-blinded, parallel, randomized study
clocortolone pivalate cream 0.1% (Cloderm® Cream 0.1%) and tacrolimus ointment 0.1% (Protopic Ointment 0.1%) bd vs clocortolone pivalate cream 0.1% bd vs tacrolimus ointment 0.1% bd
Global response
Concomitant therapy minimized the adverse effects of both treatments taken alone and potentially improved overall response
Traulsen et al. [50]
Randomized, double-blind, left–right comparison trial
Hydrocortisone buteprate cream 0.1% o.d. vs betamethasone valerate 0.1% cream o.d. for 2 weeks
Erythema, infiltration, lichenification, scaling, vesiculation, papules, excoriations and pruritus on a 0–4 scale Patient-assessed efficacy and investigator global assessment
There were no significant differences between the two treatments
Trookman et al. [51]
Single-centre, randomized, evaluator-blinded, parallel-comparison, non-inferiority study
Desonide gel 0.05% bd vs desonide ointment 0.05% bd for 4 weeks
Disease severity, body surface area involvement, subjective assessments of symptoms, corneometry, transepidermal water loss, and the patient’s preference for vehicle attributes
Desonide hydrogel was preferred by patients
Ulrich et al. [52]
Randomized, double-blind study
0.05% Halometasone cream b.d. vs 0.25% Prednicarbate cream b.d. (both topical steroids) for 2 weeks
Clinical effectiveness (doctor-assessed, fivepoint scale), onset of clinical effectiveness (doctor-assessed), adverse effects and cosmetic acceptability (patient-assessed fivepoint scale)
Clinical effectiveness: no significant difference between groups; onset: no difference at Day 1 or 4 between groups; adverse effects: none reported and cosmetic acceptability: 51% vs 46% rated it ‘excellent’
Veien et al. [53]
Randomized, double-blind, left–right comparison trial
Hydrocortisone 17-butyrate (Locoid) cream 0.1% vs hydrocortisone (Uniderm) 1% cream for 4 weeks
Global severity of all lesions
Complete clearance of skin symptoms was found in 60% hydrocortisone 17-butyrate-treated patients compared with 30% hydrocortisone 1% treated patients
Vernon et al. [54]
Randomized, double-blind parallel-group trial
Mometasone furoate 0.1% cream vs hydrocortisone 1.0% cream o.d. for 6 weeks
Doctor-assessed erythema, lichenification, skin surface disruption (crusting, scaling), excoriation, and pruritus on a 0–3 scale, % body surface area and global evaluation
Mean percentage improvement in total sign/ symptom score was 95% for mometasone vs 75% for hydrocortisone
Wolkerstorfer et al. [55]
Randomized, double/single-blind/open/cluster, controlled trial
Fluticasone propionate 0.05% cream o.d. vs clobetasone butyrate 0.05% cream b.d. for 4 weeks
SCORAD composite scale of extent and intensity of eight signs
At week 4, three fluticasone patients and one clobetasone patient clinically healed
Yasuda et al. [56]
Randomized, double-blind study
Hydrocortisone 17-butyrate 0.1% locoid ointment vs triamcinolone acetonide 0.1% ointment or hydrocortisone acetate 1% ointment for 1 week
Decrease in erythema, scaling, oedema, subjective symptoms such as pruritus and burning sensation and improvement of lesions
Hydrocortisone 17-B superior to triamcinolone and comparable to hydrocortisone
The aforementioned trials showed remarkable improvement in 13–100% of patients, following treatment with TCs for 1–12 weeks. Nineteen studies showed significantly better response to topical corticosteroids, when compared with placebo. To be precise, the older trials (in terms of the year they were published) showed more favourable response to TCs. On the other hand, three studies could not demonstrate a significant difference between the groups receiving topical corticosteroids and placebo. Five RCTs have clearly demonstrated that the number of acute episodes of flare can be significantly reduced by intermittent treatment with a potent topical corticosteroid. Three RCTs and two small within-patient comparison studies have investigated the role of wet-wrap bandages on the top of TCs. To summarize, we cannot recommend the ‘best’ TC, because there is not a single RCT, which has compared the effectiveness, safety and tolerability of all the available preparations of similar potency. Besides, there is no high-level scientific evidence supporting the application of twice-daily over once-daily TCs. However, it can be definitely concluded that application of twice-weekly potent TC to cases of stable eczema can significantly reduce the number of acute episodes in adults and children. However, the long-term safety profile of such intermittent therapy is yet to be found [57].
In a systematic review of treatments for atopic eczema, short term randomized controlled trials evaluated the effects of topical corticosteroids on pituitary–adrenal axis. It must be noted that these studies could not demonstrate any harm on the axis [58]. There is no high-level scientific evidence that correct use of topical steroids (proper potency, duration and amount) can lead to thinning of skin.
4.2.2 Vitiligo
Vitiligo is an acquired cutaneous disorder of pigmentation, characterized by destruction of melanocytes. Available therapeutic modalities include topical and systemic corticosteroids, topical immunomodulators, photo(chemo)therapy, surgery and depigmentation of normally pigmented skin. Immunosuppressive therapy with highly potent topical corticosteroids (clobetasol) gives excellent results in cases of localized stable vitiligo [59–61].
In this section, we have tabulated the evidences available in favour of using topical corticosteroids in vitiligo.
Name of study | Type of study | Intervention | Outcome measures | Result |
|---|---|---|---|---|
Koopmans-van Dorp et al. [62] | Randomized controlled trial | Betamethasone 17-valerate in a dimethyl sulfoxide cream base vs placebo | Repigmentation in the vitiliginous areas | 42% patients receiving steroids showed excellent repigmentation |
Bleehen et al. [63] | Randomized controlled trial | 0.I% betamethasone valerate (BV) or with 0.05% clobetasol propionate (CP) creams vs placebo for 3 months | Repigmentation in the vitiliginous areas | Excellent results with topical steroids |
Clayton et al. [64] | Randomized double-blind controlled trial | 0.05% clobetasol propionate in a cream base vs cream base alone | Repigmentation in the vitiliginous areas | Active product was significantly superior to the cream base alone |
Kandil et al. [65] | Randomized controlled trial | 0.1% betamethasone valerate in 50% isopropyl alcohol vs alcohol base | Repigmentation in the vitiliginous areas | Higher percentage of lesions had complete repigmentation with active product in comparison to placebo |
Lepe et al. [66] | Randomized double-blind trial | 0.1% tacrolimus vs 0.05% clobetasol | Characteristics of pigment, time of response, symptoms, telangiectasias, and atrophy | Tacrolimus and clobetasol propionate, both were equally effective |
Sanclemente et al. [67] | Randomized, matched-paired, double-blind trial | 0.05% betamethasone vs. topical catalase/dismutase superoxide (C/DSO) for 10 months | Skin repigmentation by digital morphometry | Topical C/DSO and 0.05% betamethasone, both showed good results |
Kumaran et al. [68] | Randomized trial | Betamethasone dipropionate (0.05%) cream bd vs calcipotriol ointment (0.005%) bd vs betamethasone dipropionate (0.05%) in the morning and calcipotriol (0.005%) in the evening | Skin repigmentation by digital morphometry | Combined therapy showed faster and stable repigmentation and with lesser side effects |
Xing et al. [69] | Open, uncontrolled trial | topical calcipotriol 0.005%vs betamethasone dipropionate 0.05% ointment bd for 12 weeks | Skin repigmentation by digital morphometry | Calcipotriene 0.005% and betamethasone dipropionate 0.05% ointment is effective |
Agarwal et al. [70] | Randomized, placebo-controlled, double-blind, parallel study | oral levamisole (150 mg for adults and 100 mg for children) on 2 consecutive days in a week plus mometasone furoate cream (0.1%) once a day vs oral placebo plus mometasone furoate cream once a day for 6 months | Cessation of spread of vitiligo. DLQI, CDLQI, World Health Organization Quality of Life Brief Questionnaire | Levamisole was not much effective in arresting disease progression. Cessation of spread of disease was similar in both groups (both received mometasone) |
Akdeniz et al. [71] | Randomized parallel-group study | Topical calcipotriol, NB-UVB, and betamethasone (1) vs NB-UVB and topical calcipotriol (2) vs NBUVB alone (3) for 6 months | Percentage improvement in repigmentation, DLQI and VAS | Statistically significant difference between groups 1 and 3 |
Kathuria et al. [72] | Randomized parallel-group study | 0.1% tacrolimus ointment twice daily vs 0.05% fluticasone propionate cream once daily for 6 months | Percentage of repigmentation | Both tacrolimus and fluticasone propionate produced variable results in segmental vitiligo |
Khalid et al. [73] | Randomized parallel-group study | Topical PUVAsol vs clobetasol propionate (0.05%) cream bd for 6 months. Each group received treatment for 6 weeks followed by a gap of 2 weeks | Repigmentation | Clobetasol showed favourable response |
Köse et al. [74] | Randomized parallel-group study | 0.1% mometasone furoate cream (M-Furo) once daily vs 1% pimecrolimus cream (Elidel) twice daily for 12 weeks | Degree of repigmentation | Mometasone cream was found to be effective in vitiligo on any part of the body but Pimecrolimus was effective on the face only, in childhood localized vitiligo |
Lim-Ong et al. [75] | Randomized, double-blind, placebo-controlled, within-participants, left/right comparison study | Clobetasol propionate ointment and NBUVB vs placebo and NBUVB for 6 months | Repigmentation and Cessation of spread | Group receiving clobetasol showed better response |
Sassi et al. [76] | Randomized parallel-group study | 308 nm laser phototherapy twice weekly in combination with hydrocortisone 17-butyrate cream twice daily vs 308 nm laser phototherapy twice weekly alone | Percentage repigmentation and Patient-rated quality of life: Skindex-29 | Recalcitrant vitiligo of face and neck showed good results with combination of excimer laser phototherapy with topical hydrocortisone 17-butyrate cream |
Wazir et al. [77] | Randomized parallel-group study | Topical mometasone furoate 0.01% ointment vs Topical tacrolimus 0.03% ointment and mometasone furoate 0.01% for 6 months | Repigmentation measured by comparing the treated areas with pretreatment photographs with responses graded on a scale from 0–5 | Mometasone when combined with tacrolimus showed good results |
Westerhof et al. [78] | Randomized, parallel-group, left/right comparison study | Fluticasone propionate 0.5% (FP) alone on one side of the body and FP + UVA on the other vs UVA alone on one side, and FP + UVA on the other for 9 months | Repigmentation | Combination treatment with FP and UV-A is much more effective in reaching complete repigmentation than are FP and UV-A used alone |
Yaghoobi et al. [79] | Randomized parallel-group study | 0.05% clobetasol propionate cream in isopropyl alcohol 65° preparation (in equal proportion) for the body and 0.1% triamcinolone acetonide cream for the face and flexures, used twice daily vs 0.05% clobetasol propionate cream in isopropyl alcohol 65° preparation (in equal proportion) for the body and 0.1% triamcinolone acetonide cream for the face and flexures with oral zinc sulphate capsules for 4 months | Percentage of repigmentation, assessed at 1, 3, 4 months after beginning of treatment | Clobetasol, triamcinolone and zinc showed excellent results in vitiligo |
A meta-analysis, an additional systematic review, and several RCTs showed that class 3 TCs are effective in comparison with placebo, either alone or more so in combination with NB-UVB, or psoralen plus UVA light (using sunlight or artificial light sources), in treating generalized and localized vitiligo. There is some RCT evidence that topical clobetasol propionate is of equivalent effectiveness with tacrolimus in treating this condition. All studies examining the effect of TCs reported adverse effects, with the more frequent being atrophy, telangiectasia, hypertrichosis and acneiform papules [80].
4.2.3 Psoriasis
Topical steroids are used since ages to treat mild-to-moderate plaque psoriasis. These are available in different potencies and formulations but their use relies mostly on the basis of individual experience. Here is a brief summary of evidences in favour of using topical steroids in psoriasis [81, 82].
Name of study | Type of study | Intervention | Outcome measures | Result |
|---|---|---|---|---|
Shupack et al. [83] | Randomized double-blind, parallel clinical trial | Diflorasone diacetate ointment 0.05% versus betamethasone dipropionate ointment 0.05% | Erythema, scaling, induration or the investigator’s global evaluation | Both showed good results but no statistically significant difference between the two groups with respect to erythema, scaling, induration or the investigator’s global evaluation |
Sears et al. [84] | Double-blind, randomized, placebo-controlled | Hydrocortisone buteprate 0.1% cream vs placebo | Erythema, scaling, induration or the investigator’s global evaluation | Hydrocortisone group showed good results |
Peharda et al. [85] | Randomized double-blind, parallel clinical trial | Mometasone furoate 0.1% ointment and betamethasone dipropionate 0.05% ointment | Erythema, scaling, induration or the investigator’s global evaluation | Both showed good results but betamethasone group was better |
Lebwohl et al. [86] | Randomized, double-blind, placebo-controlled study | Clobetasol propionate 0.05% foam bd vs placebo | Investigator’s and subject’s global assessment of the response and severity of erythema, scaling, and plaque thickness | Clobetasol propionate foam is more effective than placebo in the treatment of non-scalp psoriasis |
Koo et al. [87] | Randomized, controlled, double-masked, parallel-group, multicentre | Mometasone furoate 0.1%-salicylic acid 5% ointment versus mometasone furoate 0.1%ointment | Severity of erythema, induration, and scaling | Mometasone furoate-salicylic acid ointment provides more effective treatment of moderate-to-severe psoriasis than does mometasone furoate ointment alone and is safe and well tolerated |
Medansky et al. [88] | Single-centre, randomized, double-masked, intraindividual, bilateral-paired comparative trial | Mometasone furoate 0.1%-salicylic acid 5% ointment twice daily versus fluocinonide 0.05%ointment twice daily for 21 days | Signs of psoriasis (i.e., erythema, induration, and scaling) and overall clinical response | Mometasone furoate 0.1%-salicylic acid 5% ointment was more efficacious than and equally as safe as fluocinonide 0.05% ointment |
Tiplica et al. [89] | Randomized, parallel multicentre trial | Mometasone furoate 0.1% and salicylic acid 5% for 7 days followed by mometasone furoate 0.1% for 14 days vs mometasone furoate 0.1% for 21 days | Psoriasis Area Severity Index (PASI) score and Dermatology Life Quality Index (DLQI) | The sequential treatment mometasone furoate 0.1% and salicylic acid 5% followed by mometasone furoate 0.1% proves to be efficient, safe and an excellent option and better than the other group |
Guenther et al. [90] | Multicentre, investigator-blinded, parallel-group study | Tazarotene 0.1% gel once daily plus mometasone furoate 0.1% cream once daily versus calcipotriene 0.005% ointment twice daily for 8 weeks | Global improvement, plaque elevation, scaling, erythema, and percentage of body surface area involvement, efficacy of study treatment compared with previous therapies, comfort of treated skin, outlook for long-term control of psoriasis, and overall impression of treatment | Both groups showed excellent response, but the one receiving both tazarotene and mometasone was better |
Green et al. [91] | Multicentre, investigator-masked, randomized, parallel-group | Tazarotene 0.1% gel alone vs tazarotene plus a high-potency topical corticosteroid (fluocinonide 0.05% ointment, mometasone furoate 0.1% ointment, or diflorasone diacetate 0.05% ointment), vs tazarotene plus a mid-high-potency topical corticosteroid (betamethasone dipropionate 0.05% cream, fluticasone propionate 0.005% ointment, or diflorasone diacetate 0.05% cream) all applied once daily for 12 weeks | Global improvement, plaque elevation, scaling, erythema, and pruritus. Patients also rated their treatment in terms of efficacy, tolerability and satisfaction | Betamethasone dipropionate 0.05% cream (a mid-high-potency steroid) was the best option followed by mometasone furoate 0.1% ointment (a high-potency steroid) and diflorasone diacetate 0.05% ointment (a high-potency steroid) |
Katz et al. [92] | Randomized, prospective double-blind bilateral comparative clinical trial | Fluocinonide 0.05% cream (Lidex) vs fluocinonide 0.05% cream (Vasoderm) | Reduction in erythema, induration, scale and overall severity | Lidex’ cream demonstrated significantly greater reduction in erythema, induration, scale and overall severity in psoriatic activity |
Koo et al. [93] | Randomized, multicentre sequential study | Clobetasol foam plus calcipotriene ointment or either agent as monotherapy for 2 weeks | Reduction in erythema, induration, scale and overall severity | combination of clobetasol foam and calcipotriene ointment is significantly more effective than monotherapy for short-term treatment |
Ellis et al. [94] | Multicentre, evaluator-blind, parallel-group study | New formulation of betamethasone dipropionate 0.05% cream, augmented formulation (AF), od vs fluocinonide 0.05% cream bd | Erythema, induration, and scaling, as well as the physicians’ and patients’ global evaluations of response | Results significantly favoured betamethasone dipropionate AF over fluocinonide |
Greenspan et al. [95] | Double-blind, randomized, parallel study | 0.05% desonide lotion vs 0.05% desonide cream tds for 3 weeks | Reduction in erythema, induration, scale and overall severity | New lotion formulation of desonide was equivalent in both efficacy and safety to a 0.05% cream formulation |
Frost et al. [96] | Double-blind, randomized, parallel-group | Alclometasone dipropionate vs desonide ointments (0.05%) bd for 3 weeks | Erythema, induration and scaling | Both showed excellent results but differences between the groups were not statistically significant, but trends consistently favoured alclometasone |
Cornell et al. [97] | Randomized, parallel-group, double-blind study | Amcinonide ointment 0.1 percent twice daily and fluocinonide ointment 0.05 percent three times daily for 2 weeks | Erythema, induration and scaling | Amcinonide ointment 0.1 percent applied twice a day was found to be as effective and acceptable to patients as was fluocinonide ointment 0.05 percent applied three times a day in the treatment of psoriasis |
Angelo et al. [98] | Double-blind, randomized, right-left comparison study | Once-daily tazarotene 0.1% cream with that of once-daily clobetasol propionate 0.05% cream for 12 weeks | Erythema, induration and scaling | Topical tazarotene 0.1% cream was less effective than topical clobetasol propionate 0.05% cream in the treatment of plaque psoriasis |
Senter et al. [99] | Double-masked, randomized, concurrently controlled clinical trial | Once-daily fluocinonide (Lidex), combined with three-times-a-day application of its vehicle vs four-times-a-day Lidex for 4 weeks | Erythema, induration and scaling | Once-a-day application of fluocinonide was equally effective as four-times-a-day application |
Bernhard et al. [100] | Randomized, double-blind, and vehicle-controlled | 0.05% halobetasol ointment over vehicle bd for 2 weeks | Plaque elevation, erythema and scaling | 0.05% halobetasol ointment was much favourable than the vehicle |
Fleming et al. [101] | Randomized, parallel-group, double-blind, exploratory study | Calcipotriol plus betamethasone dipropionate gel compared with its active components in the same vehicle and the vehicle alone | Erythema, induration and scaling | Two-compound gel was safe and more efficacious than its individual ingredients |
Gottlieb et al. [102] | Multicentre, randomized, double-blinded, placebo-controlled study | Clobetasol propionate foam 0.05% bd vs placebo for 2 weeks | Erythema, induration and scaling, Patient’s Global Assessment score | Clobetasol propionate foam 0.05% is safe and effective for the treatment of plaque-type psoriasis |
Jarratt et al. [103] | Multicentre, randomized, double-blinded, vehicle-controlled, parallel-group, comparative study | Clobetasol propionate spray 0.05% vs vehicle for 4 weeks | Scaling, erythema, plaque elevation, pruritus and overall disease severity | Clobetasol propionate spray 0.05% administered twice daily for 4 weeks was effective and safe |
Kaufmann et al. [104] | Randomized double-blind study | Combination ointment with betamethasone dipropionate ointment, calcipotriol ointment and ointment vehicle | Scaling, erythema, plaque elevation, pruritus and overall disease severity | Calcipotriol/betamethasone dipropionate combination ointment used once daily is well tolerated and more effective than either active constituent used alone |
Mraz et al. [105] | Randomized parallel clinical study | Clobetasol propionate (CP) 0.05% (Clobex Spray; Galderma Laboratories, L.P., Fort Worth, TX, USA vs Olux Foam; Stiefel/Connetics Corp., Coral Gables, FL, USA) | Scaling, erythema, plaque elevation, pruritus and overall disease severity, DLQI | Spray was better than foam |
Singh et al. [106] | Randomized, observer-blind clinical trial | Augmented betamethasone dipropionate 0.05% cream once daily in the first and third weeks and calcipotriene 0.005% ointment twice daily in the second and fourth weeks. Vs augmented betamethasone once daily for 4 weeks | Scaling, erythema, plaque elevation, pruritus and overall disease severity, DLQI, PASI | Use of augmented betamethasone and calcipotriene on alternate weeks was more effective than daily corticosteroid
Related posts: Evolution and Development of Topical Corticosteroids
Pros and Cons of Topical Corticosteroids in Lactating Females
 Topical Corticosteroids: Pharmacology
 Systemic Side Effects of Topical Corticosteroids
 Use and Misuse of Topical Corticosteroid in Genital Dermatosis
 Topical Corticosteroid Abuse: Southeast Asia Perspective
 Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
Get Clinical Tree app for offline access
|