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

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

MedlinePlus related topics:

Acne

ChemIDplus related topics:

Benzoyl peroxide Clindamycin Clindamycin hydrochloride Clindamycin palmitate Clindamycin Palmitate Hydrochloride Clindamycin phosphate Adapalene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

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 ]

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

Intervention Details:

Applied once daily at bedtime

Applied once daily in the morning

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

Contacts


Contact: Luz E Colon, MS	817-961-5243	lucy.colon@galderma.com

Locations


United States, California
	Center for Dermatology and Laser Surgery	Recruiting
	Sacramento, California, United States, 95819
	Contact: Regan Johnson 916-454-5922 dictationet@mgci.com
	Principal Investigator: Emil A Tanghetti, MD

United States, Kentucky
	Derm Research, P.L.L.C.	Completed
	Louisville, Kentucky, United States, 40217

United States, Ohio
	Brodell Medical	Recruiting
	Warren, Ohio, United States, 44483
	Contact: Sandra Treleven 330-393-4000 Sltreleven@aol.com
	Principal Investigator: Robert T Brodell, MD

United States, Oregon
	Northwest Cutaneous Research Specialists	Recruiting
	Portland, Oregon, United States, 97210
	Contact: Kristen Reid 503-226-3376 reidkri@gmail.com
	Principal Investigator: Phoebe Rich, MD

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators


Study Director:	Ron W Gottschalk, MD	Galderma Laboratories, L.P.

More Information

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

Study placed in the following topic categories:

Exanthema

Clindamycin

Facial Dermatoses

Clindamycin-2-phosphate

Facies

Skin Diseases

Benzoyl Peroxide

Adapalene

Sebaceous Gland Diseases

Acne Vulgaris

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Anti-Infective Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Enzyme Inhibitors

Pharmacologic Actions

Protein Synthesis Inhibitors

Anti-Bacterial Agents

Acneiform Eruptions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents

Analgesics

Antirheumatic Agents

Central Nervous System Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on September 05, 2008

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