A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne - Full Text View

Purpose

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

Condition	Intervention	Phase
Acne Vulgaris	Drug: Dapsone plus Adapalene Drug: Clindamycin/benzoyl peroxide plus 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:

MedlinePlus related topics: Acne

Drug Information available for: Dapsone Benzoyl peroxide Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate Adapalene Benzoyl peroxide, clindamycin drug combination

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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.
Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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.
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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).
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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).
Percent Change From Baseline in Total Lesion Count at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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).
Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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.

Enrollment:	286
Study Start Date:	August 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Aczone® Gel 5% plus Differin® 0.3% Gel 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 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. Other Names: Aczone® Gel 5% Differin® 0.3% Gel
Active Comparator: Duac® Topical Gel plus Differin® 0.3% Gel 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 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 Other Names: Duac® Topical Gel Differin® 0.3% Gel

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231334

Locations

United States, Florida

Miramar, Florida, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01231334 History of Changes
Other Study ID Numbers:	MA-ACZ1001
Study First Received:	October 28, 2010
Results First Received:	June 25, 2012
Last Updated:	June 25, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Clindamycin
Clindamycin-2-phosphate
Dapsone
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Leprostatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013