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

Acne Vulgaris Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231334
• Other study ID #: MA-ACZ1001
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2010
• Last updated: June 25, 2012
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Severe facial acne (acne vulgaris)

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Dapsone plus Adapalene
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.
• Clindamycin/benzoyl peroxide plus Adapalene
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12	GAAS was conducted by the investigator. 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 and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement.	Baseline, Week 12	No
Secondary	Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity	The overall disease severity was evaluated by the investigator at Baseline and Week 12 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. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated.	Baseline, Week 12	No
Secondary	Percent Change From Baseline in Inflammatory Lesion Counts at Week 12	Percent Change from baseline in inflammatory lesion counts (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	No
Secondary	Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12	Percent Change from baseline in non-inflammatory lesion counts (open/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 a 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	No
Secondary	Percent Change From Baseline in Total Lesion Count at Week 12	Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement).	Baseline, Week 12	No
Secondary	Percentage of Participants Demonstrating a = 1 Category Increase in Tolerability From Baseline at Week 12	The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a =1 category increase (improvement) in tolerability from baseline is calculated.	Baseline, Week 12	No