Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications

NCT01015638 | Completed Phase 4 Results

• 1 other identifier: 114546
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.

Conditions

Acne Vulgaris

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (2)

• Erythema (Redness)

  Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader. Erythema (redness) was evaluated using the following scale: Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion

  14 days

• Skin Dryness

  Visual Dryness was evaluated using the following scale: Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring

  14 days

Secondary Outcomes (10)

• Skin Moisture and Hydration

  14 days

• Changes in the Skin Surface Hydration

  14 days

• Subject Tolerability - Burning

  2 weeks

• Subject Tolerability - Stinging

  2 weeks

• Subject Assessment - Dryness

  2 weeks

Study Arms (2)

Clindamycin and BPO 5% gel

EXPERIMENTAL

Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel.

Drug: Clindamycin and BPO 5% gel

Clindamycin phosphate and BPO 2.5% gel

ACTIVE COMPARATOR

Once Daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel.

Drug: Clindamycin phosphate and benzoyl peroxide 2.5% gel.

Interventions

Clindamycin and BPO 5% gel DRUG

Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel.

Also known as: Duac Topical Gel

Clindamycin and BPO 5% gel

Clindamycin phosphate and benzoyl peroxide 2.5% gel. DRUG

Once daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel

Also known as: ACANYA Gel

Clindamycin phosphate and BPO 2.5% 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.
• 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.
• 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

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 (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.
• Use of topical retinoids or related agents for the treatment of acne or photoaging in the preceding 6 months.
• Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's facial appearance.
• Has known sensitivities or allergies to cosmetics, soaps, fragrances, or any of the ingredients in the test products.
• Is currently going through menopause and experiencing hot flashes.
• Received any investigational drug within 30 days of study day 0 or who are scheduled to receive an investigational drug other than the study product during the study.

Sponsors & Collaborators

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

Study Sites (1)

cyberDERM

Broomall, Pennsylvania, 19008, United States

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin; Gels; clindamycin phosphate; Benzoyl Peroxide; Acanya Gel

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; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

88-435-7343

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: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 31, 2017
• Results First Posted: February 13, 2012

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)