Guidelines for adults
Anatomic area
FTU required
Amount needed for twice daily regimen in g
Face and neck
2.5
2.5
Anterior and posterior trunk
7
7
Arms
3
3
Hands (both sides)
1
1
Leg
6
6
Foot
2
2
Table 11.2
FTU guidelines for childrena
Guidelines for children | ||||
|---|---|---|---|---|
Anatomic area | FTU required | Amount needed for twice daily regimen in g | ||
3–6 months | 1–2 years | 3–5 years | 5–10 years | |
Face and neck | 1/1 | 1.5/1.5 | 1.5/1.5 | 2/2 |
Arm and hand | 1/1 | 1.5/1.5 | 2/2 | 2.5/2.5 |
Leg and foot | 1.5/1.5 | 2/2 | 3/3 | 4.5/4.5 |
Anterior trunk | 1/1 | 2/2 | 3/3 | 3.5/3.5 |
Posterior trunk and buttocks | 1.5/1.5 | 3/3 | 3.5/3.5 | 5/5 |
As per conventional practice, once or twice daily application of TC is recommended [28]. Newer formulations requiring only once daily application are available [42]. It is doubtful whether more frequent administration translates into better results [43]. A review of RCTs in atopic dermatitis failed to convincingly establish better results from more frequent application of TC [44]. This instead may lead to several local and systemic side effects. Due to the stratum corneum acting as a reservoir for TC, superpotent drugs such as clobetasol propionate 0.05% cream were found to persist in stratum corneum till day 4 [45]. This may mean that a still lower frequency of an alternate or even twice a week application of TC can be advocated. During remission or in well-controlled disease, weekend TC separated by weekdays of emollients or steroid-sparing agents may suffice [40]. It is wise to tailor the frequency schedule depending on phase of the disease so as to maximize the advantages of adequate disease control, decrease local and systemic adverse effects, and improve patient compliance [19, 46]. Advise should be given to patients to start treatment as soon as signs of a flare appear and to continue for 48 h after clinical remission [47]. Patients who experience frequent, repeated outbreaks at the same body sites may benefit from the proactive application of TCS once to twice weekly at these locations even when the eczema is quiescent. This can be used safely up to 40 weeks [48].
All TCs, regardless of the potency, should ideally not be used for more than 2–4 weeks duration at a stretch. Superpotent and potent preparations need a relook after continuous use for a maximum duration of only 2 weeks [9, 28]. The absence of clinical response or worsening of lesions calls for discontinuation of TC and reevaluation of the diagnosis. Patients should be reviewed periodically taking into account the severity and site of their initial condition and potency of topical corticosteroid being used. This would mean around 4 weeks for adults and 2 weeks for children [49].
Skin penetration and absorption of drugs in normal healthy skin vary at different anatomic sites depending on the characteristics of the stratum corneum and skin lipid structure, e.g., over the eyelids, it is 300 times more than the sole [50]. The scrotum absorbs up to 40% of applied drugs, while the face and forearms have much lower absorption of 10% and 1%, respectively [40]. It can be two- to tenfold higher in diseased states, due to defective epidermal barrier. Palms and soles need to be treated with high-potency preparations, while eyelids, the groin, the axilla, and other intertriginous areas can do with medium- to low-potency TC [1, 3, 9]. It is safer to use low- to medium-potency preparation when large surface areas are involved because of the increased risk of systemic absorption.
11.5 Right TC for the Right Kind of Patient
The age, sex, expectation of the patient, and underlying special physiological conditions like pregnancy and lactation are important considerations when choosing a TC [1, 3, 9]. Children have larger surface area to body weight ratio, have difficulty in metabolizing potent corticosteroids, and so may be more sensitive to stronger TC [40, 51]. In them, low-potency corticosteroid for short periods without occlusion is preferable. In the elderly, skin fragility may risk increased adverse effects unless milder TC is used. Though all TCs are classified category C by the US Food and Drug Administration [52], the Australian government’s Therapeutic Goods Administration(TGA) classifies some like fluocinolone, betamethasone, triamcinolone, and even halcinonide (though strength not mentioned) as category A [53]. Limited and inconclusive data for humans seems to suggest an association between very potent topical corticosteroids and fetal growth restriction [54]. As of now, there are no reported adverse effects during lactation, though direct application over nipples should be avoided before breastfeeding [40].
11.6 Right Use of TC in Combination with Antibacterials, Antifungals, and Other Agents
Perhaps no other pharmacologically active molecule has been combined in so many combinations and permutations and for so many indications as TC. To mention and discuss all will be beyond the scope of this chapter. Briefly and commonly, TC is prescribed by dermatologist in combination with antibacterials for lesions of atopic dermatitis (AD) [55]; antifungals for inflammatory and very itchy lesions of tinea and even chronic paronychia [56, 57]; emollients, salicylic acid, vitamin D analogs, and tazarotene for psoriasis [58–60]; and hydroquinone and tretinoin for melasma [61]. The rationale behind some of these is as follows:
- a.
- b.
Bioavailability and activity of the antimycotic are increased, and inflammatory symptoms are rapidly reduced on adding TC in highly inflammatory tinea [56].
- c.
Salicylic acid increases penetration of TC, enhancing its efficacy in psoriasis [58].
- d.
Early and greater efficacy and steroid-sparing effect of vitamin D analogs when combined with TC [59].
- e.
TC reduces the potential irritancy of tazarotene apart from having a synergistic effect in psoriasis [60].
Caution points and proper measures to be remembered are:
- 1.
Inappropriate use of TC + antimicrobials increases the risk of bacterial resistance and sensitization and can increase the cost of treatment [49]. TC containing antimicrobials should only be used when dermatitis is not responding despite adequate TC alone, for dermatitis associated with mild clinical infection in localized areas and for no longer than 2 weeks. It is felt that combination is more appropriate for treating eczematous lesions close to the anterior nares, flexures, perianal areas, and finger or toe web spaces [64]. They should not be issued as repeat prescriptions.
- 2.
Indiscriminate use of TC+ antifungal is thought to be one of the reasons for increasing incidence of difficult to treat tinea infections which is being experienced by almost all dermatologists in India. Complete avoidance of this combination, using them only for the first week in inflammatory or severely symptomatic patients, and using topical antifungals with additional anti-inflammatory properties may be a way forward.
- 3.
- 4.
To prevent steroid toxicities when adding salicylic acid to TC, it is recommended that this combination be limited to no more than medium-potency (class 3–4) TC.
- 5.
Combination therapies including TC for melasma should not be used for more than 4 weeks. In Indian scenario, it is better to opt for safer alternative due to prevalence of more abuse than proper use [66].
In the 1980s, triple combinations of TC, antibacterial, and antifungal were very popular and apparently very effective [67, 68]. Presently these unethical and irrational fixed drug combinations (FDC) containing 3–4 active ingredients are among the top sellers in the market [15]. Today, there is no doubt in the fraternity that they were more of a way to escape from committing to a diagnosis while offering temporary relief and have caused terrible harm over the years. They should be a strict no for the dermatologist.
11.7 Right Choice of TC When Multiple Choices Are Available
There will be times when there are many TCs available of the same class which are likely to be effective for the stage and extent of disease in a case. In this case, ethics call for prescribing the product with the lowest acquisition cost, taking into account pack size, extent of disease, and frequency of application required. It is better to be familiar with few drugs in each class rather than be swayed by the temptation to try newer things each time as per the persistence of the pharmaceutical executives who visit our hospitals and clinics. Disproportionately costly drugs offering no clinical advantage should be avoided [49]. Efficacy between generic and branded drugs even of the same compound may differ and so may their cost which should be kept in mind [28, 32]. TCs in combination packs are fairly costly and should not be used unless there is appropriate justification [5]. The only probable reason for choosing a costlier of the equipotent clinically effective TC would be the patient preference in terms of its aesthetic quality, all other things being equivalent.
11.8 Right Knowledge of Adverse Effects of TC
Details of the well-known cutaneous and systemic adverse effects [52, 69–73] are covered in other chapters of this book and will be omitted here. Reversible suppression of the hypothalamic–pituitary–adrenal axis has been described in children with TC doses as little as 14 g per week [40].
The phenomena of steroid addiction, tachyphylaxis, and contact dermatitis (CD) due to TC are issues to be aware of while treating the patient for a dermatoses or encountering one in a grip of steroid abuse. The adverse effects increase with potency of steroid, duration of use, amount applied, site of application, age of the patient, and conditions of application like hydration, occlusion, combination with salicylic acid, etc. TC addiction is an underreported entity caused due to inappropriate use of TC and probably includes several erythema syndromes such as red face syndrome, post-peel erythema, red scrotal syndrome, vulvodynia, perianal atrophoderma, chronic actinic dermatitis, and chronic recalcitrant eczemas [69, 70]. A recent systemic review of TC withdrawal revealed 34 studies involving TC addiction mostly on the face and genital area (99.3%) of women (81.0%) due to long-term inappropriate use of potent TCS [6]. Burning and stinging were the most frequently reported symptoms (65.5%) with erythema being the most common sign (92.3%). TC abuse on the face manifests as “topical corticosteroid-induced rosacea-like dermatitis” (TCIRD) or “topical steroid-dependent face” (TSDF) [17, 74]. It is very difficult to manage due to a compromised epidermal barrier as well as due to a rebound flare-up of skin lesions on attempting withdrawal of TC [17, 74].
11.9 Right Education Regarding the Use of TC
It is known that peer pressure, rapid feel good effect, and ignorance about harmful effects lead to TC abuse [16]. The excessive obsession with fairness has led to the unprecedented, unsupervised use of triple combination creams containing TC which are approved primarily as a short-term treatment for melasma and other hyperpigmented disorders. Time spent in educating on these points will hopefully prevent mishaps. It will also take care of the other extreme of excessive fear of using TC which leads to inadequate usage and poor clinical results.
Perhaps the beginning can be done by proper education of ourselves and our residents in medical colleges to write out a proper prescription especially when TC is prescribed. It should contain relevant information regarding diagnosis, site, frequency, and duration of treatment, something glaringly missing in most prescriptions [3]. From the patients’ point of view, they need to be counseled about having realistic expectations regarding outcomes: “control not cure” of the underlying disease needs to be stressed. In long-standing disease like childhood atopic dermatitis, patients and caregivers should be actively involved in disease management [48, 75].
On the other hand, topical corticosteroid concerns (TCC)/corticosteroid phobia has become an important issue in patients, parents of children with atopic dermatitis, clinicians, dermatologist, and pharmacist leading to nonadherence involving TC use, with poor disease control and increased healthcare costs [8, 76–78]. The prevalence of TCC was 41.5% among patients in a questionnaire-based study [8], while clinicians showed minor TCC themselves in 74% in another study [77]. Corticophobia among parents continues to be high resulting in undertreating their children especially in cases of AD [18]. The source of negative attitude about TC was found to be the Internet, media, family, friends, and also pharmacist and doctors. Confusing information is being received many times by parents and caregivers accessing online discussion forums regarding the use of TC [77]. Proper education about safe and rational use of TC and provision of written and oral information have led to positive change in attitude of pharmacist [76] and significant reduction in TCC in patients [8].
11.10 Right Administrative Measures Regarding the Use of TC
According to Drugs and Cosmetics (D and C) Act 1940, the TC falls under the category of Schedule H drugs, to be sold only on the valid prescription of a qualified doctor [79]. This had never been seriously implemented due to prevailing confusions [15]. Lack of qualified dermatologists, more so in rural areas, is also compounding the problem of irrational use of TC [5]. Presently more than 119 FDC formulations are available in Indian market, though only 60 are featured among the Central Drugs Standard Control Organization’s (CDSCO’s) approved list of FDCs permitted for continued manufacturing and marketing in respect of the applicants under 18-month policy decision in India (as of December 16, 2016) [81]. For the pharmaceutical companies that are marketing non-approved FDCs, the regulator needs to take stern steps to enforce law of the land by putting in place improved surveillance mechanisms. More than 7.5 lakh chemists in India, who are the point of first contact for majority of Indian population for minor healthcare ailments, need to be involved in fight against menace of TC abuse [5]. The Medical Council of India is also encouraging addition of postgraduate seats in all medical specialties in both government and private medical colleges to improve doctor/patient ratio.
Conclusions
TCs are a wonderful group of drugs in the correct hands. This implies that their benefits are far greater than their potential adverse effects when used for the appropriate dermatoses, in appropriate potency and strength for the site and severity of disease, for the appropriate duration keeping in mind the patient’s age, sex, physiologic state, and to an extent his/her esthetic needs. Awareness of TC-related adverse effects helps to put in place urgent preventive and therapeutic measures. Temptation to use TC for undiagnosed rash or in combination therapies which are expensive and of unproven additional advantage should be resisted. To ensure that rational and ethical use of TC percolates to the ground level, an ongoing multipronged approach involving medical fraternity, pharmaceutical industry, and political and legal establishment should be undertaken [16].
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