Digital Videography Assessment of Patients’ Experiences Using Adapalene-Benzoyl Peroxide Gel in the Treatment of Acne Vulgaris
August 2012 | Volume 11 | Issue 8 | Original Article | 919 | Copyright © August 2012
Steven R. Feldman MD PhD,a Richard G. Fried MD PhD,b James H. Herndon, Jr. MD,c Lori Johnson PhD,d Norman Preston PhD,d Ronald W. Gottschalk MD,d and Scott W. Caveney MD PhDe
aWake Forest University, School of Medicine, Winston Salem, NC bYardley Dermatology, Yardley, PA cThomas J. Stephens & Associates, Inc., Dallas Research Center, Carrollton, TX dGalderma Laboratories, L.P., Fort Worth, TX eSouthlake, TX
Abstract
Background: Acne profoundly affects patients' lives, but the effect of treatment is not fully characterized.
Objective: The purpose of this study was to explore patients' experiences and viewpoints regarding treatment for mild to moderate acne vulgaris.
Methods: This was an open-label, single-center study of 30 patients with mild to moderate acne vulgaris, treated with adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO gel) once daily for 12 weeks. An acne-specific quality of life questionnaire (Acne-QoL©) was conducted.
Each subject's global assessment (SGA) was recorded at baseline and weeks 4, 8, and 12. Photographs were taken and video interviews were recorded. Local tolerability assessments and incidence of adverse events were documented.
Results: A statistically significant number of patients were clear/almost clear (treatment success) at week 12 (P<.001). At week 12, patients
experienced a 44.1% and 57.1% mean reduction in inflammatory and noninflammatory lesions, respectively. By week 12, 67% of the patients in the video population (n=27) believed they had achieved treatment success (P<.001). Patients reported higher Acne-QoL© scores at week 12 compared to baseline, indicating better quality of life after treatment with adapalene-BPO gel (P<.001 for all domains). No unexpected adverse or serious adverse events were reported.
Limitations: This was an open-label study of 12 weeks duration.
Conclusion: Overall, patients with mild to moderate acne treated with adapalene-BPO gel showed significant improvement in disease severity and quality of life. The video recordings chronicled the patients' experiences throughout the treatment process.
J Drugs Dermatol. 2012;11(8):919-925.
INTRODUCTION
Acne is a chronic condition with a prolonged course, slow onset, acute outbreaks, and a pattern of recurrence and relapse.1,2 Acne can have psychological and social consequences,
3 like a deleterious effect on self-esteem, self-confidence, and therefore, overall quality of life.4-6 A recent study showed that individuals with acne are perceived more negatively than their clear-skinned counterparts.3 Other studies show that teens and young adults with acne are more frequently victims of bullying and may be less successful in dating.7,8
The benefits of adapalene-BPO have been reported previously. The efficacy of this fixed-dose combination gel has been demonstrated
in several clinical trials.11-15 The medication significantly reduces acne lesion counts as early as 1 week after therapy begins.
15 Adapalene-BPO gel is well tolerated11 and helps to prevent acne relapses.12 One-year data show that adapalene-BPO gel is safe and effective for long-term acne management.16
While multiple studies show the efficacy and safety of adapalene-BPO gel for acne, data are limited about the impact on the quality of life and experiences during treatment. The purpose of the current study was to assess experiences using adapalene-BPO gel to treat mild to moderate acne vulgaris and to document the treatment experience as told by the subjects through digital videography. Typical efficacy and safety assessments were also conducted.
METHODS
Study Design
This was an open-label, single-center study, involving 30 patients
(NCT01209949 on ClinicalTrials.gov). The study lasted 12 weeks with visits at screening, baseline, week 4, week 8, and week 12 or early termination. The protocol was reviewed and approved by a central institutional review board (IRB), IntegReview
(Austin, TX). The study was conducted in accordance with the federal and local regulatory requirements. Patients were fully informed about the study and consented to participate (informed
assent completed for minor patients).
Inclusion/Exclusion Criteria
Key inclusion criteria were: men or women aged 16 to 25 years with mild to moderate facial acne (investigator's global assessment
[IGA] = 2 or 3); a minimum of 10 inflammatory lesions
