Transitioning From Brand to Generic With Topical Products and the Importance of Maintaining the Formulation and Therapeutic Profiles of the Original Product: Focus on Clocortolone Pivalate 0.1% Cream

July 2014 | Volume 13 | Issue 7 | Supplement Individual Articles | 77 | Copyright © July 2014

James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb

aLas Vegas Skin and Cancer Clinics/West Dermatology Group, JDRx Dermatology LL C, Henderson, NV;
Touro University College of Osteopathic Medicine, Henderson, NV
bIndiana University School of Medicine, Indianapolis, IN; Icahn School of Medicine at Mount Sinai, New York, NY;
Physicians Skin Care, PLL C, Louisville, KY

table 3
tively treated with clocortolone pivalate 0.1% cream.11,12 Overall, the efficacy and safety outcomes observed in these clinical trials were favorable as depicted in Table 2.

Treatment of Facial Dermatoses

In clinical trials with clocortolone pivalate 0.1% cream, facial application over the designated study durations (range 2-4 weeks) was included for 147 study patients, especially those affected by SD and AD.11 In this subset, the efficacy, tolerability, and safety outcomes were consistent with the overall results from the trial. The results of an analysis of patients with facial dermatoses who were treated with clocortolone pivalate 0.1% cream 3 times daily for 21 days are shown in Table 2. It is important that use of any TCS on the face be limited in duration through proper monitoring, with treatment-free periods interspersed as necessary if chronic administration is required for disease control. In addition, avoidance of prolonged continuous application to the eyelids and intertriginous areas is advised as a general caution with TCS use.

Additional Data of Clinical Relevance

A subset of study subjects with chronic eczematous dermatoses and psoriasis (n=27) were treated over more prolonged durations with clocortolone pivalate 0.1% cream at sites of active skin disease (mean 116.4 days).11 No adverse reactions related to treatment were noted other than mild dryness in one patient. The use of any TCS to adequately manage a given skin disorder over prolonged durations of therapy warrants appropriate