or cosmetic purposes, transepidermal water loss (TEWL) may be increased secondary to damage to the stratum corneum (SC) permeability barrier. The decreased hydration of facial skin SC may increase skin sensitivity resulting in reduced tolerability
to applied products, including some topical corticosteroid (TC) formulations, and increased percutaneous penetration. An
important clinical observation is that facial skin is more sensitive to the adverse effects of TC with a high predilection for atrophy, telangiectasia, persistent erythema and edema, rosaceaform eruptions, perioral dermatitis, and acneiform eruptions.4
Despite the common awareness in dermatology that TCs should be used cautiously when treating facial skin, hard data from
clinical studies on the incidence of adverse reactions to individual
TC formulations applied specifically to facial skin are not available.2 One reason for this is the lack of detailed reporting requirements
at the time when many TCs were studied years ago. Additionally, the study designs needed to truly assess for TC-induced adverse reactions on facial skin are much different and more prolonged than protocols used to evaluate for efficacy and tolerability. In this article, the results of a study evaluating the treatment of inflammatory facial dermatoses with clocortolone pivalate 0.1% cream is reported. Clocortolone pivalate 0.1% cream,indicated for the relief of the inflammatory and pruritic manifestations
of corticosteroid-responsive dermatoses, is a mid-potency TC (Class 4). The chemical structure of clocortolone pivalate is similar to flumethasone pivalate (Locorten), a TC that is approved for use in Canada. Both flumethasone and clocortolone pivalate are fluorinated, although the structural details of clocortolone pivalate are distinctly different with the fluorine atom in the 6α position and the chlorine atom in the 9α position of the core nucleus. This positioning of the halogen atoms provides Class 4 efficacy for clocortolone pivalate, with a favorable efficacy and safety profile based on clinical studies in adults and children.5 An overall discussion of TC use on the face is also included
below based on literature review.
METHODS
Forty subjects <12 years of age and >19 years of age were
enrolled in this open-label study. The age exclusion between 13 and 19 years of age was mandated within the final study protocol to avoid acne-affected and acne-prone skin as a potential complicating
factor that could affect study evaluations. All enrolled subjects were diagnosed with one of four inflammatory dermatoses
involving the face (Table 1), including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Subjects were excluded if they had applied a TC to facial skin within one month prior to the study. Concurrent medications during the study that could influence efficacy, skin tolerability, and/or other safety outcomes
were prohibited. All subjects used clocortolone pivalate 0.1% cream (Cloderm® Cream, Promius Pharma, LLC) 3 times daily (morning, afternoon, evening) for 21 days.
A baseline evaluation was completed to ensure enrollment of the subject based on inclusion and exclusion criteria required in the protocol. Efficacy and safety assessments were completed at Days 4, 7, 14, and 21. Assessment of the level of improvement based on evaluation of specific clinical features was documented
at each follow-up visit using the following ranking system: Good Improvement, Improvement, No Improvement. Improvement
ratings were determined by the levels of change in erythema, edema, transudation (exudation) lichenification, and scaling, and subjective assessments of the degree of relief from pruritus and/or pain. An additional independent assessment
