parameter, the overall therapeutic response was collectively based on the above parameters, rapidity of onset of a response, and the maximum degree of lesion clearing using the following rating system: Excellent, Good, Fair, No Change, or Worse.
Safety was assessed both from reporting by study subjects and through updated history and clinical assessments completed at each study visit.
The demographic characteristics of the subjects enrolled is shown in Table 2. The majority of subjects were Caucasian females.
The age of enrolled ranged from 1 month to 88 years.
Thirty-eight subjects were included in the final efficacy analyses.
Eleven subjects failed to return after the baseline visit (lost to follow-up).
At the end of treatment, 29 subjects (76%) were rated as improved
when their condition at the initial and final visits were compared. Determination of a ranking of Improvement was based on decreases in erythema, edema, transudation, lichenification,
scaling, and relief of pruritus and/or pain (Figure 1). Twenty-five subjects (68%) had a good to excellent Overall Therapeutic Response (Figure 2). There were seven adverse events (AEs) reported during the study, judged by the investigator
to be probably related to study drug (Table 3). All of these AEs were application site reactions, with one patient, five patients,
and one patient exhibiting mild, transient burning upon study drug application, mild acneform eruptions, and folliculitis,
The results of this study show that clocortolone pivalate 0.1% cream, a mid-potency (Class 4) TC, was effective for the treatment of inflammatory facial dermatoses with very few side effects. Six of the seven AEs are known to occur with TC use, especially on facial skin, and resolve after discontinuation of therapy. The very low risk of cutaneous irritation with clocortolone pivalate 0.1% cream is not surprising as the formulation contains three agents that assist in maintaining SC permeability barrier integrity (white petrolatum, stearyl alcohol [long chain fatty acid emollient], and mineral oil) and is lanolin-free, propylene glycol-free, short-chain alcohol-free, and devoid of fragrances. This study is one of the few that was designed to determine the safety and efficacy of
TC used to treat facial involvement with one of the common inflammatory dermatoses. Among inflammatory facial skin diseases, the most frequently studied is seborrheic dermatitis (SD).6,7,8,9,10,11,12 These studies demonstrated the effectiveness and favorable safety profiles of several mid to low-potent TCs for facial SD when used appropriately over short durations of therapy. The TCs evaluated in these studies included desonide 0.05% lotion, hydrocortisone 1% ointment, desonide 0.05% hydrogel, desonide 0.05% cream, hydrocortisone acetate 1% cream, hydrocortisone 1% cream, and clocortolone 0.1% pivalate cream. However, TC cannot be used continuously for prolonged durations for SD or other dermatoses, with facial skin demonstrating a high propensity
for TC-induced side effects.13 This observation is illustrated in one more recent study of a low-potency TC in which 86% of patients with facial SD who had cleared after applying desonide 0.05% cream twice daily for 14 days relapsed at some point over the subsequent 14 days (post-treatment study phase) where no treatment was used.9
Flares of atopic dermatitis is frequently treated with TCs but only a few studies have been conducted to evaluate the outcomes of treatment specifically for facial lesions.2 The effectiveness, safety, and patient acceptability of desonide 0.05% lotion, a low potency (Class 6) TC, was compared to its vehicle lotion for the treatment of facial atopic or seborrheic dermatitis.6 In the desonide lotion group there were twelve patients with atopic dermatitis and twenty-eight with seborrheic dermatitis. Patients used the lotions twice daily for 3 weeks. Efficacy results for both diagnoses collectively revealed that 57% of patients cleared in the desonide lotion group and 11% cleared in the vehicle group. Cutaneous tolerability was rated as excellent for most patients in the desonide lotion group, with a mean global assessment score of 4.8 on a 5 point scale which ranged from Unacceptable (1) to Excellent (5). Two patients in the desonide lotion group experienced cutaneous adverse events (“rash” and pruritus). It is important to note that several TC compounds and vehicles are widely available as various brands, and most are available as generic formulations. As topical formulations with the same active ingredient and concentration may differ in their pharmacokinetic
(PK) properties (ie, active drug release characteristics, percutaneous penetration) and “inert” ingredients, it is not automatically accurate to assume that the efficacy and tolerability
results reported with a given brand formulation would be the same with other formulations, especially generic versions
where efficacy, tolerability, and PK data are often (but not always) meager or nonexistent.