Clinical Trial of Lupeol for Mild-moderate Acne

Acne Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152865
• Other study ID #: anti-acne product
• Status: Completed
• Phase: N/A
• First received: May 25, 2014
• Last updated: May 28, 2014
• Start date: December 2009
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Seoul National University Institutional Review Board, Seoul: Korea
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• Lupeol
Patients are supposed to apply lupeol cream to one side of their face two times per day for 8 weeks.
• Control vehicle
Patients are supposed to apply their control vehicle to the other side of their face for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acne lesion counts as a measure of efficacy	Both inflammatory & non-inflammatory acne lesions of both of their facial sides	8 weeks after beginning of applications	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Among total patients enrolled in this study, number of patients either experiencing objective adverse events or subjective uncomfortableness were counted	8 weeks after beggning of applications	Yes