Clinical Trial of Lupeol for Mild-moderate Acne

Not Applicable

Completed

• Conditions: Acne
• Interventions: Drug: Lupeol; Drug: Control vehicle

• Registration Number: NCT02152865
• Lead Sponsor: Seoul National University Hospital

Brief Summary

For the chemical lupeol isolated from eggplant, we applied it to one side of face, and applied vehicle control to another side for 8 -weeks. The study was performed in a 8-week, randomized controlled, split face fashion. Investigators evaluated safety and efficacy during baseline, 2 weeks, 4weeks, and 8 weeks after beginning of study.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-05-25
• Study First Submitted QC: 2014-05-28
• Last Update Submitted: 2014-05-28
• Study First Posted: 2014-06-02
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients over the age 15 who were clinically diagnosed with mild to moderate acne vulgaris

Exclusion Criteria

• ; known pregnancy or lactation, any medical illness that might influence the results of the study, a previous history of oral acne medication or surgical procedures including laser treatment within 6 month and topical medication within 4 weeks of study enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lupeol	Lupeol	Patients are supposed to apply lupeol on one side of face two times per day for 8 weeks
Control vehicle	Control vehicle	Patients are supposed to apply vehicle control to another side of face two times per day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Acne lesion counts as a measure of efficacy	8 weeks after beginning of applications	Both inflammatory \& non-inflammatory acne lesions of both of their facial sides

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	8 weeks after beggning of applications	Among total patients enrolled in this study, number of patients either experiencing objective adverse events or subjective uncomfortableness were counted

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of