Pilot Randomized-Control Trial to Assess the Effect Product Sampling has on Adherence Using Adapalene/Benzoyl Peroxide Gel in Acne Patients
February 2014 | Volume 13 | Issue 2 | Original Article | 135 | Copyright © February 2014
Laura F. Sandoval DO,a Ashley Semble MS,a Cheryl J. Gustafson MD,a Karen E. Huang MS,a Michelle M. Levender MD,a and Steven R. Feldman MD PhDa,b,c
aDepartment of Dermatology, Center for Dermatology Research, Wake Forest School of Medicine, Winston-Salem, NC
bDepartment of Pathology, Wake Forest School of Medicine, Winston-Salem, NC
cDepartment of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC
PURPOSE: To determine whether demonstrating to patients how to properly apply a topical acne medication through the use of a sample product will improve adherence.
METHODS: Subjects with mild to moderate acne were instructed to use adapalene/benzoyl peroxide gel once daily for six weeks. Subjects were randomized into sample or no sample group. Sample group received a demonstration on how to apply the medication using a product sample. The primary outcome was median adherence, recorded using electronic monitoring, and secondary outcomes were efficacy measures including the Acne Global Assessment (AGA) and lesion counts and the Perceived Medical Condition Self-Management Scale (PMCSMS).
RESULTS: Data from 17 patients was collected and analyzed. Median adherence rates were 50% in the sample group and 35% in the no sample group (p=0.67). The median percent improvement in non-inflammatory lesions were 46% for the sample group and 33% for the no-sample group (p=0.10).
LIMITATIONS: The small size of this pilot study limited the extent of subgroup analyses.
CONCLUSIONS: Objective electronic monitoring expanded our previous observations of poor adherence in the treatment of acne. There is a considerable potential effect size on adherence for the use of samples, supporting the need for future, well powered studies to assess the value of using samples in the treatment of acne and other dermatologic skin diseases.
J Drugs Dermatol. 2014;13(2):135-140.