A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions

NCT02052752 | Completed Phase 4 Results

• 2 other identifiers: 201244RH02060
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

5 Day study to assess how quickly a topical acne product begins to work.

Conditions

Skin Diseases

Outcome Measures

Primary Outcomes (1)

• To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.

  The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure

  Baseline to Day 4

Secondary Outcomes (5)

• To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.

  Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4

• To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.

  Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4

• To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.

  Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4

• To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel

  Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4

• To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel

  Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4

Study Arms (3)

Test Product

EXPERIMENTAL

Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.

Drug: 3% Benzoyl Peroxide

Vehicle gel

ACTIVE COMPARATOR

The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.

Drug: 3% Benzoyl Peroxide Placebo

Positive control

PLACEBO COMPARATOR

A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.

Drug: Neutrogena Rapid Clear®

Interventions

3% Benzoyl Peroxide DRUG

Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.

Test Product

3% Benzoyl Peroxide Placebo DRUG

The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.

Vehicle gel

Neutrogena Rapid Clear® DRUG

A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.

Positive control

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
• Fitzpatrick Skin Type I - V.
• Male or female aged from 12 to 45 years, inclusive, at time of consent.
• Mild to moderate facial acne vulgaris as determined by the Investigator, with a minimum of 10 inflammatory lesions (papules plus pustules, including nasal lesions) and a minimum of 10 non-inflammatory lesions (open and closed comedones, including nasal lesions).
• Three appropriate and evaluable target lesions, as judged by the Investigator.
• Able to complete the study and to comply with study instructions.
• Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Acceptable contraceptive methods include the following:
• Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed.
• Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female participant has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Participants with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermicide is acceptable.
• Women who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.

You may not qualify if:

• Has any nodulocystic lesions at the baseline evaluation.
• Female who is pregnant, trying to become pregnant, or breastfeeding.
• Has active or chronic skin allergies.
• Has a history of acute or chronic disease that might interfere with or increase the risk of study participation.
• Had skin cancer treatment in preceding 12 months.
• Has damaged skin on facial areas (e.g., sunburn, tattoo, or scar).
• Had any medical procedure (e.g., laser resurfacing, chemical peel, or plastic surgery) on facial areas in preceding 12 months.
• Had any cosmetic procedure (e.g., microdermabrasion) on facial areas within 8 weeks of the baseline visit.
• Has any dermatological disorder that in the opinion of the Investigator may interfere with the accurate evaluation of the participant's facial appearance.
• Received any investigational drug or procedure within 28 days of study day 1 or is scheduled to receive an investigational drug (other than the study products) or procedure during the study.
• Currently using any medication that in the opinion of the Investigator may affect the evaluation of the study products or place the participant at undue risk.
• Has a history of known or suspected intolerance to any of the ingredients of the study products (i.e., benzoyl peroxide).
• Considered unable or unlikely to attend the necessary visits.
• Has used non-steroidal anti-inflammatory drugs for the treatment of acne or for treatment durations longer than 7 days for any condition.
• Uses oil-based sunscreens or sunscreens containing active ingredients that may have an effect on acne.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Conditions

Skin Diseases

Interventions

Benzoyl Peroxide

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 3, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 18, 2015
• Results First Posted: May 18, 2015

Record last verified: 2015-05

Locations

US (1)