Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications

NCT ID: NCT00926367

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-07-31

Brief Summary

This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product

Detailed Description

This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product.

The subjects will be entered into a 2-week treatment phase. The once-daily applications for the study medication will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays.

A blinded expert grader will rate comparative product tolerance on each week day (excluding Saturdays and Sundays) during the study before study product is applied.

Subject questionnaires will be completed along with collection of all adverse events.

Conditions

Acne Vulgaris

Study Design

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

Study Groups

Clinidamycin/ Benzoyl Peroxide

Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide (BPO).

Group Type: EXPERIMENTAL

Clindamycin and benzoyl peroxide

Intervention Type: DRUG

Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.

Benzoyl peroxide and adapalene

Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide (BPO) and adapalene

Group Type: ACTIVE_COMPARATOR

benzoyl peroxide 2.5% and adapalene 0.1% gel

Intervention Type: DRUG

Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel

Interventions

Clindamycin and benzoyl peroxide

Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.

Intervention Type: DRUG

benzoyl peroxide 2.5% and adapalene 0.1% gel

Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel

Intervention Type: DRUG

Other Intervention Names

Duac® Topical Gel (clindamycin and benzoyl peroxide.; benzoyl peroxide gel and adapalene gel

Eligibility Criteria

Inclusion Criteria

• Subjects 18 to 45 years of age or older, able to complete the study and comply with study instructions.
• Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception
• 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.
• Is willing to discontinue use of all facial products (other than the cleanser provided and makeup or razor and facial shave product) on the face for the 3 days before their baseline/day 0 visit and use only the provided facial products and their normal makeup or razor and facial shaving product for the duration of the study.
• Is willing to avoid sunburn, tanning, tanning beds or other excessive sun exposure. Understands that if their skin tone changes significantly during the study it will be necessary to discontinue their participation.

Exclusion Criteria

• Male subjects that have facial beards (mustache and/or goatee is acceptable).
• Is a Type I diabetic.
• 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.
• Has participated in other facial studies in the preceding 30 days or other clinical studies in preceding 14 days.
• Had skin cancer treatment in preceding 12 months.
• Has damaged skin on facial areas (eg, from sunburn, tattoos, scars).
• Had any medical procedure (eg, laser resurfacing, chemical peels, plastic surgery) to facial areas in preceding 12 months.
• Had any cosmetic procedure (eg, microdermabrasion, etc.) to facial areas within 8 weeks of the baseline visit.
• Live in the same household as currently enrolled subjects.
• Any other condition or factor the investigator or his duly assigned representative believes may affect the skin response or the interpretation of the test results.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Stiefel, a GSK Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

cyberDERM

Broomall, Pennsylvania, United States

Countries

United States

Other Identifiers

C0000-405

Identifier Type: -

Identifier Source: org_study_id