Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1% - Full Text View

Sponsored by:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00599521

Purpose

The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Adapalene Drug: Vehicle	Phase III

MedlinePlus related topics: Acne

Drug Information available for: Adapalene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Galderma:

Primary Outcome Measures:

Percent of subjects who have at least a 2 point reduction at week 12 in the IGA score from baseline, and absolute change from baseline to week 12 in inflammatory, non-inflammatory, and total lesion counts. [ Time Frame: 1 wk, 2 wks, 4 wks, 8 wks, and 12 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline to week 12 in inflammatory, non-inflammatory, and total lesion counts. [ Time Frame: 1 wk, 2 wks, 4 wks, 8 wks, and 12 wks ] [ Designated as safety issue: No ]

Enrollment:	1067
Study Start Date:	November 2007
Study Completion Date:	December 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Adapalene Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
B: Placebo Comparator	Drug: Vehicle Vehicle will be applied topically to the face, once a day, for 12 weeks

Detailed Description:

This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

Eligibility

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

Criteria

Inclusion Criteria:

Subjects with Moderate or Severe Acne Vulgaris,
20-50 papules and pustules in total on the face excluding the nose
30-100 non-inflammatory lesions on the face excluding the nose.
Negative urine pregnancy test for all females.

Exclusion Criteria:

Subjects with more than one acne nodule.
Subjects with any acne cyst on the face.
Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea.
Subjects who are pregnant, nursing, or planning a pregnancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599521

Show 34 Study Locations

Sponsors and Collaborators

Galderma

More Information

Responsible Party:	Dow Pharmaceutical Sciences, Inc. ( Barry M. Calvarese, Vice President Regulatory and Clinical Affairs )
Study ID Numbers:	RD.06.SPR.18114, IND 076057
Study First Received:	January 11, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00599521
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Galderma:

Acne Vulgaris
Adapalene

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies
Skin Diseases

Adapalene
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Physiological Effects of Drugs
Pharmacologic Actions
Acneiform Eruptions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009