Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

This study has been completed.

First Received: January 22, 2009 No Changes Posted

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00829049

Purpose

Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris

Condition	Intervention	Phase
Acne Vulgaris	Drug: Tazarotene Cream 0.1% Drug: Adapalene	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Adapalene Tazarotene

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Non-inflamed lesion counts (open/closed comedones) [ Time Frame: Day 0 (baseline), Weeks 2, 4, 8, 12, 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigator Global Assessment [ Time Frame: Day 0 (baseline), Weeks 2, 4, 8, 12, 16 ] [ Designated as safety issue: No ]
Overall Disease Severity [ Time Frame: Day 0 (baseline), Weeks 2, 4, 8, 12, 16 ] [ Designated as safety issue: No ]
Inflamed Lesion Counts (papules/pustules, nodules) [ Time Frame: Day 0 (baseline), Weeks 2, 4, 8, 12, 16 ] [ Designated as safety issue: No ]

Enrollment:	180
Study Start Date:	October 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Tazarotene Cream 0.1%	Drug: Tazarotene Cream 0.1% 1 pea-size amount, QD x 16 weeks
2: Active Comparator Adapalene Gel 0.3%	Drug: Adapalene 1 pea-size amount, QD x 16 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.

Exclusion Criteria:

Non-compliance with washout period
Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
Allergy or sensitivity to any component of the test medications
Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829049

Locations

United States, California

Fremont, California, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Vice President Medical Affairs )
Study ID Numbers:	MA-TAZ0702
Study First Received:	January 22, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00829049 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Inflammatory Agents
Niacinamide
Facial Dermatoses
Adapalene
Sebaceous Gland Diseases
Acne Vulgaris
Keratolytic Agents
Nicotinamide
Nicotinic Acids
Exanthema
Vitamins
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Micronutrients
Nicotinic Acid
Tazarotene
Vitamin B Complex
Skin Diseases
Facies
Trace Elements
Vitamin B3
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Niacin

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Facial Dermatoses
Physiological Effects of Drugs
Adapalene
Sebaceous Gland Diseases
Acne Vulgaris
Keratolytic Agents
Nicotinic Acids
Sensory System Agents
Acneiform Eruptions
Therapeutic Uses
Vitamins
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Micronutrients
Dermatologic Agents
Tazarotene
Vitamin B Complex
Skin Diseases
Growth Substances
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009