A Long-Term Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris - Full Text View

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00446043

Purpose

This is a multi-centre, open-label, non-comparative study to evaluate the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.

Subjects are evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.

Safety is evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (haematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy is evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject’s Assessment of Acne.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Adapalene/Benzoyl Peroxide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Long-Term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Adapalene

U.S. FDA Resources

Further study details as provided by Galderma:

Estimated Enrollment:	452
Study Start Date:	February 2004
Estimated Study Completion Date:	May 2004

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A clinical diagnosis of acne vulgaris with facial involvement
A minimum of 20 but not more than 50 Inflammatory lesions
A minimum of 30 but not more than 100 Noninflammatory lesions

Exclusion Criteria:

Subjects with presence of nodules or cysts.
Acne conglobata, acne fulminans, secondary acne, or severe acne.
Underlying diseases that require the use of interfering topical or systemic therapy.
Use of prohibited medications prior to the study unless appropriate washout period is documented

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446043

Locations

United States, Oregon
Phoebe Rich, MD
Portland, Oregon, United States, 97210

Sponsors and Collaborators

Galderma

Investigators

Study Director:

Michael Graeber, MD

Galderma

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. Review.

Study ID Numbers:	RD.06.SPR.18089
Study First Received:	March 8, 2007
Last Updated:	March 8, 2007
ClinicalTrials.gov Identifier:	NCT00446043 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Galderma:

Acne Vulgaris
Adapalene
Benzoyl Peroxide

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Facial Dermatoses
Skin Diseases
Physiological Effects of Drugs
Benzoyl Peroxide
Sebaceous Gland Diseases
Adapalene
Acne Vulgaris
Pharmacologic Actions
Sensory System Agents

Acneiform Eruptions
Analgesics, Non-Narcotic
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 February 09, 2010