A 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:	NCT00421993

Purpose

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.

The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle 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:

Primary Outcome Measures:

Success Rate on the Investigator's Global Assessment [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Changes in Inflammatory Lesion Counts [ Time Frame: from Baseline to week 12 ] [ Designated as safety issue: No ]
Changes in Noninflammatory Lesion Counts [ Time Frame: from Baseline to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent Change in Inflammatory Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Percent Change in Noniflammatory Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Percent Change in Total Lesion Counts [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Enrollment:	1670
Study Start Date:	October 2006
Study Completion Date:	December 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Adapalene/Benzoyl Peroxide Topical Gel	Drug: Adapalene/Benzoyl Peroxide Topical Gel, One application daily in the evening for 12 weeks
2: Active Comparator Adapalene Topical Gel	Drug: Adapalene Topical Gel,One application daily in the evening for 12 weeks
3: Active Comparator Benzoyl Peroxide Topical Gel	Drug: Benzoyl Peroxide Topical Gel, one application daily in the evening for 12 weeks
4: Placebo Comparator Topical Gel Vehicle	Drug: Topical Gel Vehicle Topical Gel Vehicle,one application daily in the evening for 12 weeks

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
A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

Exclusion Criteria:

More than one acne nodule or any acne cyst.
Acne conglobata, acne fulminans, secondary acne, or severe acne.
Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
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
Use of hormonal contraceptives solely for control of acne

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421993

Show 62 Study Locations

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.

Responsible Party:	Galderma ( Michael Graeber, MD, Head of US Development )
Study ID Numbers:	RD.06.SPR.18088
Study First Received:	January 11, 2007
Results First Received:	January 15, 2009
Last Updated:	October 19, 2009
ClinicalTrials.gov Identifier:	NCT00421993 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 November 25, 2009