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Clinical Trial of Lupeol for Mild-moderate Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 25, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date June 2, 2014
Study Start Date  ICMJE December 2009
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Lupeol for Mild-moderate Acne
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Lupeol
    Patients are supposed to apply lupeol on one side of face two times per day for 8 weeks
    Intervention: Drug: Lupeol
  • Placebo Comparator: Control vehicle
    Patients are supposed to apply vehicle control to another side of face two times per day for 8 weeks
    Intervention: Drug: Control vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2014)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152865
Other Study ID Numbers  ICMJE anti-acne product
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dae Hun Suh, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP