Trial for the Clinical Evaluation of the Quality of Life of the Subject, the Efficacy and the Tolerance of Duac® Gel Against Differin® Gel in the Topical Treatment of Mild to Moderate Acne Vulgaris - Full Text View

Sponsored by:	Stiefel Laboratories
Information provided by:	Stiefel Laboratories
ClinicalTrials.gov Identifier:	NCT00807014

Purpose

The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Duac Gel Drug: Differin gel	Phase IV

MedlinePlus related topics: Acne

Drug Information available for: Adapalene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Single-Blind, Multicenter, Parallel, Comparative, Randomized, Phase IV Clinical Trial for the Clinical Evaluation of the Quality of Life of the Subject, the Efficacy and the Tolerance of Duac® Gel (Gel With Clindamycin Phosphate [Equivalent to 1% Clindamycin] and 5% Benzoyl Peroxide) Against Differin® Gel (Gel With 0.1% Adapalene) in the Topical Treatment of Mild to Moderate Acne Vulgaris.

Further study details as provided by Stiefel Laboratories:

Primary Outcome Measures:

Quality of Life [ Time Frame: Start of study to week 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation between the quality of life questionnaire scores and the total lesion count [ Time Frame: Start to week 2 ] [ Designated as safety issue: No ]
Change in the percentage of inflammatory, non-inflammatory and total lesions [ Time Frame: Start to week 2 ] [ Designated as safety issue: No ]

Enrollment:	169
Study Start Date:	November 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Duac Gel	Drug: Duac Gel Duac® Gel will be applied to the face once daily at night, for 12 weeks.
2: Active Comparator Differin gel	Drug: Differin gel Differin Gel will be applied to the face once daily at night, for 12 weeks.

Detailed Description:

Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It is characterized by the formation of comedones, papules, pustules, nodules, cysts, maculae and scars, generally located on the face, chest and back. Acne pathogenesis is recognized as multifactorial.

Acne vulgaris is the most common dermatological disorder. It affects approximately 85% individuals at some point in their lives, generally between 12 and 24 years of age. Although acne is prevalent within this age range, it can persist for many years and its long-term physical and psychological implications can be significant.

There are several medicinal products used to treat acne. However, the therapeutic challenge remains, therefore it is essential to continue investigating effective strategies for the treatment of this disease.

Eligibility

Ages Eligible for Study:	12 Years to 39 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with mild to moderate acne vulgaris on the face,.
Subjects of either sex aged between 12 and 39 years, inclusive.
Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study.

Exclusion Criteria:

Women who are pregnant, breast-feeding, or sexually active with the potential to have children, and not using a contraception method that is safe from a medical point of view
Subjects using anti-androgen containing contraceptives.
Subjects who, during the past month, have received oral or topical steroids or antibiotics, or acne treatment of any type, including natural or artificial UV therapy.
Subjects who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the medicinal products which will be used during the study.
Subjects using, or having used in the past month, any significant concomitant medicinal product which might affect their acne, as judged by the Investigator.
Subjects with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
Subjects with a history of photosensitivity.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807014

Locations

Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Ramón and Cajal
Madrid, Spain, 28034
Hospital Germans Trias I Pujol
Badalona, Spain, 08916
Hospital del Mar
Barcelona, Spain, 08003
Hospital Abente y Lago in La Coruna
La Coruna, Spain
Hospital Clínico de Salamanca
Salamanca, Spain, 37007
Clínica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital Clínico Universitario Ntra. Sra. de the Victoria
Málaga, Spain, 29010

Sponsors and Collaborators

Stiefel Laboratories

Investigators

Study Director:	David A Angulo, MD	Sr. Director Global Clinical Research, Stiefel Laboratories, Inc.
Principal Investigator:	Aurora Guerra Tapia, MD	Hospital Universitario 12 de Octubre

More Information

No publications provided

Responsible Party:	Stiefel Laboratories, Inc ( Jason Mann, Director Global Clinical Operations )
Study ID Numbers:	S194-SP-05/Duac
Study First Received:	December 10, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00807014 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Stiefel Laboratories:

Acne Vulgaris
Acne
Duac
Differin
quality of life

Study placed in the following topic categories:

Anti-Inflammatory Agents
Clindamycin
Facial Dermatoses
Skin Diseases
Facies
Clindamycin-2-phosphate
Quality of Life
Benzoyl Peroxide
Sebaceous Gland Diseases

Adapalene
Acne Vulgaris
Exanthema
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Facial Dermatoses
Skin Diseases
Physiological Effects of Drugs
Sebaceous Gland Diseases
Adapalene
Acne Vulgaris
Pharmacologic Actions
Acneiform Eruptions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 06, 2009