A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne

NCT01231334 | Completed Phase 4 Results

• 1 other identifier: MA-ACZ1001
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12

  GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.

  Baseline, Week 12

Secondary Outcomes (6)

• Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12

  Baseline, Week 12

• Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity

  Baseline, Week 12

• Percent Change From Baseline in Inflammatory Lesion Counts at Week 12

  Baseline, Week 12

• Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12

  Baseline, Week 12

• Percent Change From Baseline in Total Lesion Count at Week 12

  Baseline, Week 12

Study Arms (2)

Aczone® Gel 5% plus Differin® 0.3% Gel

ACTIVE COMPARATOR

Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks.

Drug: Dapsone plus Adapalene

Duac® Topical Gel plus Differin® 0.3% Gel

ACTIVE COMPARATOR

Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.

Drug: Clindamycin/benzoyl peroxide plus Adapalene

Interventions

Dapsone plus Adapalene DRUG

Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks.

Also known as: Aczone® Gel 5%, Differin® 0.3% Gel

Aczone® Gel 5% plus Differin® 0.3% Gel

Clindamycin/benzoyl peroxide plus Adapalene DRUG

Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks

Also known as: Duac® Topical Gel, Differin® 0.3% Gel

Duac® Topical Gel plus Differin® 0.3% Gel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Severe facial acne (acne vulgaris)

You may not qualify if:

• History of significant anemia or hemolysis
• History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)
• History of lupus, rosacea, or seborrheic dermatitis

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Miramar, Florida, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Dapsone; Adapalene; Gels; Clindamycin; Benzoyl Peroxide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives

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: October 28, 2010
• First Posted: November 1, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 27, 2012
• Results First Posted: July 27, 2012

Record last verified: 2012-06

Locations

US (1)