Clinical Study for Topical Lupeol in Acne

• ClinicalTrials.gov Identifier: NCT02205892
• Recruitment Status: Completed
• First Posted: July 31, 2014
• Last Update Posted: September 29, 2014
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Dae Hun Suh, Seoul National University Hospital

Study Description

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

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Study for the Effectiveness and Safety of Topical Lupeol in Mild to Moderate Acne
• Study Start Date: August 2014
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: September 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Lupeol	Drug: 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.
Placebo Comparator: Vehicle	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.

Outcome Measures

Primary Outcome Measures :

1. Percent change of inflammatory acne lesion counts [ Time Frame: 4 week ]

Secondary Outcome Measures :

1. Percent change of non-inflammatory acne lesion counts [ Time Frame: 4 week ]

Other Outcome Measures:

1. Change of Leeds revised grade [ Time Frame: 4 week ]

Eligibility Criteria

• 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 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.

Contacts and Locations

Locations

Korea, Republic of

Seoul National University Department of Dermatology

Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

• 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

More Information

• Responsible Party: Dae Hun Suh, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02205892 History of Changes
• Other Study ID Numbers: SNUH-lupeol
• First Posted: July 31, 2014
• Last Update Posted: September 29, 2014
• Last Verified: September 2014

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

natural product; clinical trial

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Lupeol; Anti-Inflammatory Agents