Clinical Study for Topical Lupeol in Acne
Clinical Study for the Effectiveness and Safety of Topical Lupeol in Mild to Moderate Acne
1 other identifier
interventional
16
1 country
1
Brief Summary
Double-blind, randomized,4-week small-scale clinical trial for lupeol in the treatment of inflammatory and non-inflammatory acne lesions in split face fashion
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2014
CompletedFirst Posted
Study publicly available on registry
July 31, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 29, 2014
September 1, 2014
1 month
July 30, 2014
September 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change of inflammatory acne lesion counts
4 week
Secondary Outcomes (1)
Percent change of non-inflammatory acne lesion counts
4 week
Other Outcomes (1)
Change of Leeds revised grade
4 week
Study Arms (2)
Lupeol
ACTIVE COMPARATORVehicle
PLACEBO COMPARATORInterventions
Patients are supposed to apply 2% lupeol cream to one side of their face two times per day for 4 weeks. Application side is randomly determined.
Patients are supposed to apply their control vehicle cream two times per day to the other side of their face for 4 weeks. Application side is randomly determined.
Eligibility Criteria
You may qualify if:
- Patients over the age 15 years of age or older who were clinically diagnosed with mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Department of Dermatology
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dae Hun Suh, MD
Seoul National University Department of Dermatology
- STUDY DIRECTOR
Hyuck Hoon Kwon, MD
Seoul National University Department of Dermatology
- STUDY DIRECTOR
Sun Yong Park
Seoul National University Department of Dermatology
- STUDY DIRECTOR
Seounguk Min
Seoul National University Department of Dermatology
- STUDY DIRECTOR
Jae Yoon Jung
Seoul National University Department of Dermatology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 30, 2014
First Posted
July 31, 2014
Study Start
August 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
September 29, 2014
Record last verified: 2014-09