Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications

NCT00964366 | Completed Phase 4 Results

• 2 other identifiers: 114545C0000-408
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, half-face study. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side of the face will remain non-treated to serve as a control.

Conditions

Acne Vulgaris

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

  2 Weeks

• 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 1through Day 14

Secondary Outcomes (3)

• Transepidermal Water Loss (TEWL)

  2 Weeks

• Sebum Measurements

  2 weeks

• Skin Hydration

  2 weeks

Study Arms (2)

Clindamycin/BPO gel

EXPERIMENTAL

Once-daily applications of clindamycin/BPO gel to the randomized side of the face either left or right.

Drug: clindamycin and benzoyl peroxide

Dapsone gel

ACTIVE COMPARATOR

Twice-daily applications of dapsone gel to one side of the face.

Drug: Dapsone gel

Interventions

clindamycin and benzoyl peroxide DRUG

Daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide

Also known as: Duac® gel

Clindamycin/BPO gel

Dapsone gel DRUG

Twice-daily applications of dapsone gel

Also known as: ACZONE® (dapsone) Gel, 5%

Dapsone gel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: 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.
• Male and female subjects aged from 18 to 45 years at time of consent.
• Has a Fitzpatrick Skin Type of I, II, or III.
• 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 not change brands of makeup or razor and facial shave product during the study.
• Is willing to refrain from using any facial product on the face other than study products and their normal makeup or razor and facial shave product for the duration of the study.
• Is willing to refrain from exercising prior to their instrument appointments.
• Is willing to refrain from showering or drinking caffeinated beverages within 1 hour prior to their instrument visits.
• Is willing to report to the site for each visit with a clean face and no makeup.
• 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.
• 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.

You may not qualify if:

• Female subjects who are pregnant, trying to become pregnant, or breast feeding.
• 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 (e.g., laser resurfacing, chemical peels, plastic surgery) to facial areas in preceding 12 months.
• Had any cosmetic procedure (e.g., microdermabrasion, etc.) to facial areas within 8 weeks of the baseline visit.
• Use of topical retinoids or related agents for the treatment of acne or photoaging in the preceding 6 months.
• Live in the same household as currently enrolled subjects.
• Employees of investigator/clinical research organization (CRO) or Stiefel Laboratories involved in the study, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.
• 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; Dapsone; 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; Sulfones; Sulfur Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

888-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: August 20, 2009
• First Posted: August 24, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 30, 2017
• Results First Posted: April 3, 2012

Record last verified: 2017-05

Locations

US (1)