RESUMEN
BACKGROUND: Acne is a common inflammatory disease of sebaceous glands, which brings extensive emotional and psychological distress to patients. Although acupuncture has certain advantages in the treatment of acne, the curative effect is not exact. The purpose of this trial is to evaluate the feasibility, preliminary efficacy, and safety of the "Spleen and Stomach Guiyuan Acupuncture Method" (SSGA) in the treatment of gastrointestinal damp-heat acne. METHODS: The proposed protocol is planned as a randomized, assessor-blind, conventional-treatment-controlled trial to evaluate the efficacy of SSGA on gastrointestinal damp-heat acne. Seventy six gastrointestinal damp-heat acne patients will be randomly divided into 2 groups and receive SSGA or conventional acupuncture treatment. The entire study period is 12âweeks, including an 8-week treatment period and a 4-week follow-up period. All patients will receive 16 sessions of acupuncture treatment over 8âweeks. The primary outcome is the investigation global assessment (IGA) at week 8, which is an overall assessment of the degree of the inflammatory and non-inflammatory lesion. The secondary outcomes include IGA, the total facial lesion count (Total Lesion Count), the acne-specific quality of life, etc at weeks 8 and 12. The Expectation and Credibility of treatment rating scale will be used to measure the patients' attitudes to acupuncture after the first treatment. Adverse events will also be recorded. DISCUSSION: This study is helpful to evaluate the feasibility, preliminary efficacy, and safety of SSGA in the treatment of gastrointestinal damp-heat acne. The results will be used in sample size calculations for subsequent large-scale studies.Trial registration: Chinese Clinical Trial Registry ChiCTR2100047363. Registered on June 13, 2021.