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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icariin | Experimental | 3% icariin |
|
| Control | Placebo Comparator | 3% ethanol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icariin | Drug | Topical application of 3% icariin solution |
| |
| Vehicle Control |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the total number of acne lesions and scars at 8 weeks | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C056599 | icariin |
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Split-face study
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| Drug |
Topical application of 3% ethanol solution |
|
| Change from baseline in ECCA scar grading scale 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. |
| 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 | 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) | From enrollment to the end of treatment at 8 weeks |