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

monitoring by the clinician, with vigilance regarding potential local and systemic adverse reactions.
In cutaneous safety studies, the skin irritancy potential of clocortolone pivalate 0.1% cream was determined to be neglibible.11 In one study (n=10) of extensive application of clocortolone pivalate 0.1% cream (30g twice daily) to subjects over 21 days with 12 hours of full body occlusion each day, suppression of the hypothalamic-pituitary-adrenal (HPA) axis was not observed using urinary 17-ketosteroid and serum cortisol levels at specified timepoints.11 Other studies have shown that clocortolone pivalate 0.1% cream does not induce phototoxicity or photoallergy.11

SUMMARY

This article discusses compound-related properties, vehicle characteristics, and efficacy and safety data which demonstrate that clocortolone pivalate 0.1% cream exhibits favorable pharmacologic properties, efficacy outcomes, and tolerability data. In addition, the emollient cream vehicle is well-designed for application to eczematous and inflamed skin as supported both by clinical experience and by studies evaluating favorable effects on TEWL and skin hydration (corneometry). It is beneficial for clinicians to be aware that an authorized generic of clocortolone pivalate 0.1% cream has been made available from the same manufacturer as the original brand of clocortolone pivalate 0.1% cream, with both being identical in their formulation. This assures that substitution with this specific authorized generic of clocortolone pivalate 0.1% cream does not change what the patient is receiving as compared to the brand formulation of clocortolone pivalate 0.1% cream.

DISCUSSION

This publication was supported by Promius Pharma, LLC.
Dr. Del Rosso has served as a consultant, advisory board participant, clinical investigator, and speaker for Allergan, Anacor Aqua, Bayer Healthcare (Dermatology), Dermira, Eisai, Ferndale, Galderma, Innocutis, LeoPharma, Merz Pharmaceuticals, Onset Dermatologics, Pharmaderm, Primus, Promius Pharma, Quinnova, Ranbaxy, Sebacea, Taro, Unilever, and Valeant Pharmaceuticials (Medicis, Consumer Care), and Warner-Chilcott.
Dr. Kircik has served as an advisor, investigator, consultant, and speaker for Allergan, Bayer, Galderma, Promius Pharma, Quinnova, Stiefel/GSK, LeoPharma, Taro, Valeant, and Warner-Chilcott.

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AUTHOR CORRESPONDENCE

James Q. Del Rosso DO FAOCDjqdelrosso@yahoo.com
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