THERAPEUTICS FOR THE CLINICIAN Short-Contact Clobetasol Propionate Shampoo 0.05% Improves Quality of Life in Patients With Scalp Psoriasis Jerry Tan, MD, FRCPC; Richard Thomas, MD; Béatrice Wang, MD; David Gratton, MD; Ronald Vender, MD; Nabil Kerrouche, MSc; Hervé Villemagne, MSc; for the CalePso Study Team Scalp psoriasis has a considerable impact on the on their QOL increased from 45.6% at baseline to quality of life (QOL) of patients, and most patients 81.7% at week 4. Most participants were satisfied are dissatisfied with available treatments. Clo- with the cosmetic acceptability and the efficacy betasol propionate shampoo 0.05% has been and safety aspects of the product, considered shown to be effective and safe for moderate to it better than prior treatments, and would use it severe scalp psoriasis. We evaluated the effect again in the future. Therefore, we conclude that of clobetasol propionate shampoo on QOL and treatment with clobetasol propionate shampoo the degree of participant satisfaction with the improved the QOL of participants and resulted in product. Participants received once-daily treat- high satisfaction. ment for up to 4 weeks. Their QOL and degree Cutis. 2009;83:157-164. of satisfaction were evaluated by questionnaires. The mean (standard deviation) Dermatology Life Quality Index (DLQI) score decreased signifi- calp psoriasis is a common inflammatory disease cantly from 7.0 (4.9) at baseline to 3.2 (3.2) at that has a considerable impact on the quality of week 4 (P,.001). Participants who considered S life (QOL) of patients because of its associated the disease as having a small effect or no effect pruritus, the visibility of lesions, and the chronicity of disease.1 Approximately 50% of patients in one Accepted for publication January 26, 2009. survey (N51023) reported that their scalp psoriasis 2 Dr. Tan is from Windsor Clinical Research Inc, Ontario, Canada. was psychologically disturbing and socially impeding. Dr. Thomas is from Derm Research @ 888 Inc, Vancouver, British Patients have indicated that pruritus and scaling are Columbia, Canada. Dr. Wang is from Siena Medical Research, the two most distressing and frequent symptoms.2,3 Montréal, Quebec, Canada. Dr. Gratton is from International Furthermore, because there is no cure for psoria- Dermatology Research, Montréal. Dr. Vender is from Dermatrials Research, Hamilton, Ontario, Canada. Mr. Kerrouche is from and sis, patients experience a lifelong condition with 2 Mr. Villemagne was from Medical and Marketing, Galderma R&D, frequent relapses. Sophia Antipolis, France. Topical medication remains the most frequently This study was supported by Galderma Laboratories, LP. The used treatment for scalp psoriasis in all severity clinical investigators received fees for the conduct of this study. groups.4,5 Patients have expressed a high level of Dr. Tan is an advisory board member, clinical trial investigator, consultant, and speaker for Galderma Laboratories, LP. dissatisfaction with existing treatments; common Drs. Thomas, Wang, and Gratton report no conflict of interest. complaints include side effects, lack of efficacy, Dr. Vender is an advisory board member for, has received a and inconvenience.6 Tar-based products are not research grant from, and is on the speakers program for Dermatrials widely accepted because of their unpleasant odor; Research. Mr. Kerrouche is an employee and Mr. Villemagne potential carcinogenicity; and staining of hair, was an employee of Galderma R&D until study completion. 7 Correspondence: Jerry Tan, MD, FRCPC, Windsor Clinical skin, and clothing. Vitamin D3 analogues have Research Inc, 2224 Walker Rd, Suite 300, Windsor, ON N8W 5L7, the disadvantages of possible irritation and slow Canada ([email protected]). onset of effect, while the rapid and highly effective VOLUME 83, MARCH 2009 157 Therapeutics for the Clinician topical corticosteroids may cause skin atrophy; Methods striae; telangiectasia; and rare systemic adverse This study was conducted in accordance with the events (AEs), such as hypothalamic-pituitary- Declaration of Helsinki and its amendments, man- adrenal axis suppression.8-10 Vehicles such as dates of the US Food and Drug Administration’s creams and ointments have the disadvantage of Good Clinical Practice program, and local regula- being greasy, messy, and difficult to apply, espe- tory requirements including an ethics board review. cially to the hair-bearing and relatively inacces- All participants provided written informed consent sible scalp area.11 Based on these considerations, before entering the study. products with shampoo, spray, and foam formu- Study Design and Participant Selection—This lations have been developed. A foam formula- single-arm open-label study was conducted in tion containing 60% alcohol was proposed to 12 centers in Canada and comprised the prelimi- be a preferred vehicle for delivering clobeta- nary phase of a randomized, double-blind, vehicle- sol propionate 0.05%.11,12 However, it requires controlled investigation on the maintenance twice-daily application, which may adversely effect of long-term clobetasol propionate shampoo affect adherence. treatment in scalp psoriasis. The recruited par- Facilitating adherence may be one of the most ticipants were 18 years or older, with moderate or important ways to improve the overall effec- severe scalp psoriasis based on their global severity tiveness of treatment, as surveys revealed that score (GSS) assessment (35moderate; 45severe). approximately 40% of patients with psoriasis For participants who had previously received poten- were poorly adherent to topical corticosteroid tially interfering topical or systemic treatments, a therapy.3,13,14 Discussions about QOL also could washout period was mandatory prior to entering the serve to encourage patient adherence. However, study: 2 weeks for topical treatments on the scalp, according to one survey, discussion of QOL was and 2 to 12 weeks for systemic treatments. absent in 40% of a total of 238 dermatology out- Treatment—All participants received clobetasol patient consultations.15 propionate shampoo 0.05% for up to 4 weeks. Par- A shampoo formulation integrating a superpo- ticipants were instructed to apply the study drug tent corticosteroid (clobetasol propionate 0.05%) once daily in a thin film onto dry affected scalp areas into a once-daily, short-contact formulation was and leave it in place for 15 minutes before lather- developed to minimize the risk for cutaneous ste- ing and rinsing. The use of conventional topical roidal AEs without compromising efficacy. More- therapies, except superpotent corticosteroids, was over, this formulation may be particularly suited allowed to treat body psoriasis. The study visits were for application on hair-bearing regions, such as conducted at baseline and weeks 2 and 4. the scalp. The results of a randomized, controlled, Assessment of Participant-Reported Outcomes— double-blind study demonstrated that while clo- Two self-administered questionnaires were used to betasol propionate shampoo had a safety profile evaluate participant-reported outcomes of treat- similar to the corresponding vehicle, it was signifi- ment. An evaluation of the effect of treatment cantly more efficacious for patients with moderate on skin-related QOL was performed by compar- to severe scalp psoriasis (P,.001).16 Compared ing the results of the 10-item DLQI question- with leave-on clobetasol propionate gel 0.05%, naire distributed to all participants at baseline the short-contact, rinse-off clobetasol propionate and at completion of treatment (week 4). The shampoo was equally efficacious but did not result DLQI questionnaire is a simple and practical in hypothalamic-pituitary-adrenal axis suppression, tool designed to assess the impact of different skin atrophy, or other cutaneous steroidal AEs.17 skin diseases and their treatments on the QOL Furthermore, results of 2 randomized investigator- of participants. Total DLQI score, calculated by blind studies demonstrated that the efficacy and summing the scores of each answer, has previously safety profile of clobetasol propionate shampoo was been shown to correlate with the overall impact superior to tar blend shampoo 1% and calcipotriol on skin-related QOL (0–15no effect; 2–55small solution 0.005%.18,19 effect; 6–105moderate effect; 11–205very large Although the efficacy and safety of clobeta- effect; 21–305extremely large effect).20 The dif- sol propionate shampoo have been established, ference in DLQI score before and after treatment participant-reported outcomes have not been was tested using the nonparametric Wilcoxon previously evaluated. We present participant signed rank test. Participant satisfaction and responses to a QOL index questionnaire (the preference with treatment was evaluated with a Dermatology Life Quality Index [DLQI]) and a 13-item questionnaire administered at week 4, and satisfaction questionnaire. the results were summarized descriptively. 158 CUTIS® Therapeutics for the Clinician Assessment of Efficacy and Safety—Efficacy was completing the study and only 1 discontinuation assessed by changes in GSS (05clear; 55very due to an AE (unrelated to study treatment). severe) at each study visit (baseline, weeks 2 and Participant Skin-Related QOL—We evaluated 4). Participants with a GSS of clear at week 2 ter- the impact of clobetasol propionate shampoo treat- minated the study earlier. At each visit, the partici- ment on participant skin-related QOL by comparing pants were asked to indicate their