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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02152865
Other study ID # anti-acne product
Secondary ID
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


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
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