Clinical Trial of Lupeol for Mild-moderate Acne

May 28, 2014 updated by: Dae Hun Suh, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lupeol
Patients are supposed to apply lupeol on one side of face two times per day for 8 weeks
Drug: Lupeol
Patients are supposed to apply lupeol cream to one side of their face two times per day for 8 weeks.
Other Names:
  • no brand name
PLACEBO_COMPARATOR: Control vehicle
Patients are supposed to apply vehicle control to another side of face two times per day for 8 weeks
Drug: Control vehicle
Patients are supposed to apply their control vehicle to the other side of their face for 8 weeks
Other Names:
  • No brand name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acne lesion counts as a measure of efficacy
Time Frame: 8 weeks after beginning of applications
Both inflammatory & non-inflammatory acne lesions of both of their facial sides
8 weeks after beginning of applications

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 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
8 weeks after beggning of applications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

May 25, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (ESTIMATE)

June 2, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • anti-acne product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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