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.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00829049
First received: January 22, 2009
Last updated: August 20, 2012
Last verified: August 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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%

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Tazarotene
Adapalene
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014