Comparing Lipohydroxy Acid Cream to Tretinoin

DOUBLE BLIND, RANDOMIZED, PROSPECTIVE TRIAL COMPARING A SALICYLIC ACID CREAM TO TRETINOIN CREAM FOR ACNE VULGARIS

E.M. Graber, MD*, D.M. Thiboutot†, MD, S. Seité‡, PhD, A. Rougier‡, PhD, and A.R. Shalita, MD§.

*SkinCare Physicians, Chestnut Hill, MA, USA, †Department of Dermatology, Pennsylvania State University College of Medicine, Milton S. Hershey Medical Center, Hershey, PA, USA. ‡La Roche-Posay Pharmaceutical Laboratories, Asnières, France. §Department of Dermatology, State University of New York Downstate Medical Center, Brooklyn, NY, USA.

I certify that any affiliations with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials discussed in the manuscript (eg, employment, conultancies, stock ownership, honoraria, expert testimony) is disclosed below. Any financial project support of this work is identified in an acknowledgement in the manuscript.

Supported by La Roche-Posay Pharmaceutical Laboratories.

Conflict of interest: A. Rougier and S. Seité work exclusively for La Roche-Posay Pharmaceutical Laboratories. E. Graber received an honorarium for this work. A. Shalita and D. Thiboutot served as clinical investigators for the trial.

Keyword: Acne, salicylic acid, lipophilic hydroxy acid, lipohydroxy acid, tretinoin

Abbreviations and Acronyms: ANOVA, Analysis of Variance; SA, Salicylic Acid; LHA, Lipohydroxy Acid.

Abstract

New topical treatments for acne vulgaris are needed for patients who have tolerance problems with current treatments. Salicylic acid is an over-the-counter anti-acne treatment tretinoin is a commonly used prescription anti-acne cream. We sought to compare efficacy and tolerance of a formula containing salicylic acid (SA) and a lipophilic derivative of salicylic acid (Lipohydroxy Acid or LHA) versus a tretinoin cream in subjects with mild acne vulgaris. Primarily, we wanted to establish equivalent efficacy between these two creams. We conducted a randomized, double blind, prospective trial enrolling 85 subjects with mild to moderate facial acne. All subjects had less than 10 inflammatory lesions and between 20 and 40 comedones and were randomized to receive either cream containing SA plus LHA twice a day or tretinoin once daily for 87 days. Efficacy and tolerability were assessed by both the subjects and the investigator at days 0, 28, 56 ad 87. At the conclusion of the study, subjects also completed a questionnaire with regards to efficacy and the cosmetic properties of their given cream. 73 subjects completed the study, of which 37 used SA/LHA and 36 used tretinoin. With the exception of pustules (p=0.10), all lesion types (open comedones,