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Clinical Trial of Lupeol for Mild-moderate Acne

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ClinicalTrials.gov Identifier: NCT02152865
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Dae Hun Suh, 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.

Condition or disease Intervention/treatment Phase
Acne Drug: Lupeol Drug: Control vehicle Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2009
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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 Name: 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 Name: No brand name




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152865


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Dae Hun Suh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02152865     History of Changes
Other Study ID Numbers: anti-acne product
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014

Keywords provided by Dae Hun Suh, Seoul National University Hospital:
medication

Additional relevant MeSH terms:
Lupeol
Anti-Inflammatory Agents