Background: Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested, owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the present study is to evaluate the effectiveness of acupuncture in treating the symptoms and QoL of patients with moderate or severe AV.
Methods/design: One hundred eligible participants with AV will be randomly assigned to an acupuncture or a sham acupuncture group (1:1 allocation). All participants will receive 4-week treatment comprising a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, visual analogue scale scores for assessment of itch and pain, patient expectations of acupuncture, and blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population.
Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single-center scope, relatively small sample size, and lack of blinding of the acupuncturists.
Trial registration: Chinese Clinical Trial Registry, ChiCTR-1900023649. Registered on January 2, 2019.
Keywords: Acne vulgaris; Acupuncture; Protocol; Quality of life; Randomized controlled trial.