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

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

Study Overview

• Status: Terminated
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Tazarotene Cream 0.1%; Drug: Adapalene

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Differin® Gel 0.3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at 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).	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at 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.	Week 16
Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at 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.	Week 12
Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at 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).	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 22, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Estimate): September 12, 2012
• Last Update Submitted That Met QC Criteria: August 20, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Keratolytic Agents; Tazarotene; Adapalene
• Other Study ID Numbers: MA-TAZ0702