Clinical Study for Topical Lupeol in Acne

NCT ID: NCT02205892

Last Updated: 2014-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-09-30

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

Detailed Description

To investigate the clinical efficacy and tolerability of lupeol for the treatment of facial acne, we conducted a small-scale, randomized, double-blinded, split-face clinical trial over the course of 4 weeks. Fifteen of 16 enrolled patients completed the study, in which affected areas on half each patient's face were treated with 2% lupeol twice daily while the other side of the face was treated with a vehicle control. Clinical visits were scheduled at baseline and at 2 and 4 weeks. The primary outcome of the study was the percent change in inflammatory lesions (papules, pustules, and nodules) at 4 weeks. The secondary outcomes were the percent change in non-inflammatory lesions (open and closed comedones) and the change in the Leeds revised acne grading system score at 4 weeks. Adverse events (AEs) were defined as all unintended and harmful signs or symptoms; these were assessed by both patients' self-reporting and physicians' skin examination at each visit. Results were analyzed using intent to treat (ITT) groups. The per-protocol (PP) population consisted of the 15 patients who did not have any major protocol deviations. Last observation carried forward (LOCF) analysis was used to evaluate the primary and secondary outcomes.

** Randomization and blindness process **

At the time of initial presentation, an evaluation of acne severity was performed using both individual counts of inflammatory and non-inflammatory acne lesions and an assessment of the Leeds revised acne grading system score. Then, patients were randomly assigned to either left- or right-sided lupeol application, with the other side of the face assigned to vehicle-control application. A simple random allocation sequence was created using computer-based random number generators with a block size of 4. All dermatologists participating in outcome assessments, a physician assistant managing trial enrollment and administration, medical statisticians analyzing the data, and patients were blinded to the assignments. Randomization codes were strictly secured in a safe in the administration office of the clinical research center until data entry was complete. The integrity of the blinding was ensured by packaging the study- and control products in identical tubes and by requiring a third party (other than the investigator/evaluator) to dispense the medication. In addition, both topical agents were identical in color and odor.

Conditions

Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lupeol

Group Type: ACTIVE_COMPARATOR

Lupeol

Intervention Type: DRUG

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.

Vehicle

Group Type: PLACEBO_COMPARATOR

Placebo vehicle

Intervention Type: DRUG

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.

Interventions

Lupeol

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.

Intervention Type: DRUG

Placebo vehicle

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dae Hun Suh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dae Hun Suh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Department of Dermatology

Hyuck Hoon Kwon, MD

Role: STUDY_DIRECTOR

Seoul National University Department of Dermatology

Sun Yong Park

Role: STUDY_DIRECTOR

Seoul National University Department of Dermatology

Seounguk Min

Role: STUDY_DIRECTOR

Seoul National University Department of Dermatology

Jae Yoon Jung

Role: STUDY_DIRECTOR

Seoul National University Department of Dermatology

Locations

Seoul National University Department of Dermatology

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SNUH-lupeol

Identifier Type: -

Identifier Source: org_study_id