Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 233 for:    acne AND Percent

Clinical Study for Topical Lupeol in 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: NCT02205892
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
Dae Hun Suh, Seoul National University Hospital

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.


Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205892


Locations
Layout table for location information
Korea, Republic of
Seoul National University Department of Dermatology
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
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

Layout table for additonal 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    Key Record Dates
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:
Layout table for MeSH terms
Lupeol
Anti-Inflammatory Agents