Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris

NCT00834210 | Completed Phase 4 Results

• 1 other identifier: MA-ACZ0802
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe facial acne vulgaris

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12

  Change from baseline in inflammatory lesion count (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 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 12

Secondary Outcomes (3)

• Change From Baseline in Investigator Global Assessment at Week 12

  Baseline, Week 12

• Change From Baseline in Overall Disease Severity at Week 12

  Baseline, Week 12

• Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12

  Baseline, Week 12

Study Arms (2)

1

ACTIVE COMPARATOR

Dapsone Gel 5% and Tazarotene Cream 0.1%

Drug: Dapsone

2

ACTIVE COMPARATOR

Tazarotene Cream 0.1%

Drug: Tazarotene

Interventions

Dapsone DRUG

Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks

Also known as: Aczone Gel 5%; Tazorac Cream 0.1%

1

Tazarotene DRUG

Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks

Also known as: Tazorac Cream 0.1%

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Facial acne vulgaris characterized by the following: 30-100 facial inflammatory lesions; and 25-100 facial non-inflammatory lesions; stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or more nodules and/or cysts (diameter of 1cm or greater). Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

You may not qualify if:

• Non-compliance with washout period; history of clinically significant anemia or hemolysis; skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris; allergy or sensitivity to any component of the test medications

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Fremont, California, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Dapsone; tazarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: December 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 31, 2011
• Results First Posted: October 31, 2011

Record last verified: 2011-09

Locations

US (1)