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临床试验/NCT07076784
NCT07076784已完成不适用

A Study for Evaluating the Effect and Safety of Icariin for Acne and Acne Scars

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年3月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Change from baseline in the total number of acne lesions and scars at 8 weeks

研究概览

简要总结

The goal of this clinical trial is to examine whether topical application of icariin can improve acne and atrophic acne scars in adults. The main questions it aims to answer are:

  • Does icariin reduce the number of facial acne lesions and acne scars?
  • What histological changes occur in acne or scar tissue after using icariin? Researchers will compare icariin to a vehicle control (3% ethanol solution) to assess its relative efficacy.

Participants will:

  • Apply icariin or control solution to each side of the face twice daily for 2 months
  • Visit the clinic every 4 weeks for checkup
  • Receive skin biopsies before and after the study period, if they consent to this procedure

详细描述

Acne vulgaris is one of the most common dermatologic conditions, affecting more than 80-90% of adolescents worldwide. Its pathogenesis is multifactorial, involving excessive sebum production, follicular hyperkeratinization, proliferation of Cutibacterium acnes, and inflammation. Clinical manifestations range from comedones and papules to pustules and nodules, most frequently appearing on the face. Beyond the physical burden, facial acne induces significant psychosocial distress, including anxiety, depression, and social withdrawal. Inflammatory lesions frequently progress to atrophic scars, which persist long term and further intensify psychological morbidity. Studies report acne scarring in up to 95% of patients, with approximately 30% developing scars that are severe enough to require clinical intervention.

Current treatments for atrophic acne scars-such as laser resurfacing, chemical peels, microneedling, and soft-tissue fillers-entail risks including pain, prolonged downtime, and variable efficacy. Topical pharmacologic agents, including retinoids, offer noninvasive alternatives, but their scar-remodeling effects are limited and may cause irritation or photosensitivity. Because scar formation involves a complex interplay of inflammation, collagen degradation, and impaired wound healing, there remains an unmet need for therapies that are safe, effective, and accessible, capable of addressing both active acne and established scars.

Icariin is a prenylated flavonoid glycoside isolated from Epimedium species (e.g., Yin Yang Huo, horny goat weed), traditionally used in oriental medicine as an herbal remedy and dietary tincture. It has demonstrated neuroprotective, cardiovascular, anti-osteoporotic, and antitumor effects, and is considered safe for human consumption. Preclinical evidence indicates that icariin inhibits inflammation, regulates lipid metabolism, suppresses bacterial proliferation, and promotes skin wound healing. Despite these properties, which suggest both anti-acne and pro-remodeling potential, no clinical study to date has evaluated icariin's efficacy in human acne or acne scars.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 19 to 39 with inflammatory acne and atrophic acne scars on both sides of the face

排除标准

  • Diagnosis of acne conglobata or acne fulminans
  • Pregnancy or breastfeeding
  • Presence of systemic diseases or use of medications that may affect acne or scarring
  • Presence of psychiatric disorders
  • Recent use of isotretinoin within the past 4 months
  • Use of other oral or topical acne treatments or anti-acne cosmetics within the past 2 weeks
  • Receipt of procedural treatment for acne scars (e.g. chemical peels or energy-based devices) within the past 4 weeks

研究组 & 干预措施

Icariin

Experimental

3% icariin

干预措施: Icariin (Drug)

Control

Placebo Comparator

3% ethanol

干预措施: Vehicle Control (Drug)

结局指标

主要结局

Change from baseline in the total number of acne lesions and scars at 8 weeks

时间窗: From enrollment to the end of treatment at 8 weeks

次要结局

  • Investigator's global assessment for acne (IGA)(From enrollment to the end of treatment at 8 weeks)
  • Scar global assessment (SGA)(From enrollment to the end of treatment at 8 weeks)
  • Change from baseline in ECCA scar grading scale at 8 weeks(From enrollment to the end of treatment at 8 weeks)
  • Change from baseline in the number of acne lesions and scars by size and type at 8 weeks(From enrollment to the end of treatment at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dae Hun Suh

Principal Investigator

Seoul National University Hospital

研究点 (1)

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