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Completed

NCT Number: NCT07076784

Topical Icariin on Acne and Acne Scars

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

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Key information

Age range

19 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Icariin

Drug

Topical application of 3% icariin solution

vehicle control

Drug

Topical application of 3% ethanol solution

Primary outcomes

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

    Time frame: From enrollment to the end of treatment at 8 weeks

Secondary outcomes

  1. Investigator's global assessment for acne (IGA)

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. Scar global assessment (SGA)

    Time frame: From enrollment to the end of treatment at 8 weeks

  3. Change from baseline in ECCA scar grading scale at 8 weeks

    Time frame: From enrollment to the end of treatment at 8 weeks

    The ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné; a French acronym that translates to Clinical Evaluation Scale for Acne Scars in English) is a tool designed to help dermatologists to assess the severity of acne scars. This score ranges from 0 to 540, with higher scores indicating a more severe condition.

  4. Change from baseline in the number of acne lesions and scars by size and type at 8 weeks

    Time frame: From enrollment to the end of treatment at 8 weeks

    Acne lesions by type (inflammatory and noninflammatory); acne scars by size (small-sized, < 2 mm; medium-sized, 2-4 mm; large-sized, > 4 mm) and type (icepick, boxcar, and rolling)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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