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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 terminated.
(Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.)
Information provided by (Responsible Party):
Allergan Identifier:
First received: January 22, 2009
Last updated: August 20, 2012
Last verified: August 2012
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).

Secondary Outcome Measures:
  • Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16 [ Time Frame: Week 16 ]
    Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne.

  • Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12 [ Time Frame: Week 12 ]
    Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne.

  • Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16 [ Time Frame: Baseline, Week 16 ]
    Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).

Enrollment: 165
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
Active Comparator: Tazarotene Cream 0.1%
1 pea-size amount, QD x 16 weeks
Drug: Tazarotene Cream 0.1%
1 pea-size amount, QD x 16 weeks
Other Name: TAZORAC® Cream 0.1%
Active Comparator: Adapalene Gel 0.3%
1 pea-size amount, QD x 16 weeks
Drug: Adapalene
1 pea-size amount, QD x 16 weeks
Other Name: Differin® Gel 0.3%


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00829049

United States, California
Fremont, California, United States
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan Identifier: NCT00829049     History of Changes
Other Study ID Numbers: MA-TAZ0702
Study First Received: January 22, 2009
Results First Received: September 22, 2011
Last Updated: August 20, 2012

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Nicotinic Acids
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Dermatologic Agents
Keratolytic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on April 26, 2017