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

NCT00926367 | Completed Phase 4 Results

• 1 other identifier: C0000-405
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Acne Vulgaris

Keywords

Acne

Outcome Measures

Primary Outcomes (2)

• Skin Erythema (Redness)

  Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion

  Baseline, Day 1 through Day 14

• Skin Dryness

  The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate skin dryness is: Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.

  Baseline, Day 1 through Day 14

Secondary Outcomes (16)

• Skin Moisture and Hydration

  Baseline, Days 3, 7, and 14

• Skin Hydration

  Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14

• Self Assessment of Burning

  Baseline, Day 1 through Day 14

• Self Assessment of Stinging

  Baseline, Day 1 through Day 14

• Self Assessment of Dryness

  Baseline, Day 1 through Day 14

Study Arms (2)

Clinidamycin/ Benzoyl Peroxide

EXPERIMENTAL

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

Drug: Clindamycin and benzoyl peroxide

Benzoyl peroxide and adapalene

ACTIVE COMPARATOR

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

Drug: benzoyl peroxide 2.5% and adapalene 0.1% gel

Interventions

Clindamycin and benzoyl peroxide 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.

Also known as: Duac® Topical Gel (clindamycin and benzoyl peroxide.

Clinidamycin/ Benzoyl Peroxide

benzoyl peroxide 2.5% and adapalene 0.1% gel DRUG

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

Also known as: benzoyl peroxide gel and adapalene gel

Benzoyl peroxide and adapalene

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

cyberDERM

Broomall, Pennsylvania, 19008, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin; Benzoyl Peroxide; Adapalene; Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2009
• First Posted: June 23, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 20, 2015
• Results First Posted: August 4, 2011

Record last verified: 2015-05

Locations

US (1)