NCT07076784

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

July 16, 2025

Last Update Submit

March 4, 2026

Conditions

Keywords

Icariin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

Study Arms (2)

Icariin

EXPERIMENTAL

3% icariin

Drug: Icariin

Control

PLACEBO COMPARATOR

3% ethanol

Drug: Vehicle Control

Interventions

Topical application of 3% icariin solution

Icariin

Topical application of 3% ethanol solution

Control

Eligibility Criteria

Age19 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

icariin

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split-face study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 22, 2025

Study Start

March 21, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations