NCT02152865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

4.4 years

First QC Date

May 25, 2014

Last Update Submit

May 28, 2014

Conditions

Acne

Keywords

medication

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    8 weeks after beggning of applications

Study Arms (2)

Lupeol

ACTIVE COMPARATOR

Patients are supposed to apply lupeol on one side of face two times per day for 8 weeks

Drug: Lupeol

Control vehicle

PLACEBO COMPARATOR

Patients are supposed to apply vehicle control to another side of face two times per day for 8 weeks

Drug: Control vehicle

Interventions

LupeolDRUG

Patients are supposed to apply lupeol cream to one side of their face two times per day for 8 weeks.

Also known as: no brand name
Lupeol
Control vehicleDRUG

Patients are supposed to apply their control vehicle to the other side of their face for 8 weeks

Also known as: No brand name
Control vehicle

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over the age 15 who were clinically diagnosed with mild to moderate acne vulgaris

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 Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

lupeol

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2014

First Posted

June 2, 2014

Study Start

December 1, 2009

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

KR(1)