Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris - Full Text View

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00671749

Purpose

This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Condition	Intervention	Phase
Acne Vulgaris	Drug: adapalene gel, 0.3% Drug: clindamycin/benzoyl peroxide gel	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Benzoyl peroxide Adapalene

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

Percent change from baseline in total lesion counts at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline in total lesion counts at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in inflammatory and non-inflammatory lesion counts at Weeks 6 and 12 [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
Global severity assessment at Weeks 6 and 12 [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
Global assessment of Improvement from baseline at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Tolerability assessments and incidence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	December 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Applied once daily at bedtime

Other Name: Differin® Gel, 0.3%

Applied once daily in the morning

Other Name: Duac® Gel

Detailed Description:

Same as above.

Eligibility

Ages Eligible for Study:	12 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with a minimum of 20 inflammatory lesions on the face;
Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
Subject has a Global Severity Assessment

Exclusion Criteria:

1. Subjects with more than three nodulo-cystic lesions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671749

Locations

United States, California
Center for Dermatology and Laser Surgery
Sacramento, California, United States, 95819
United States, Kentucky
Derm Research, P.L.L.C.
Louisville, Kentucky, United States, 40217
United States, Ohio
Brodell Medical
Warren, Ohio, United States, 44483
United States, Oregon
Northwest Cutaneous Research Specialists
Portland, Oregon, United States, 97210

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ron W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

No publications provided

Responsible Party:	Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00671749 History of Changes
Other Study ID Numbers:	US10066
Study First Received:	April 30, 2008
Last Updated:	September 5, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Clindamycin
Clindamycin-2-phosphate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012