A Phase 4 interventional study of Dapsone plus Adapalene and Clindamycin/benzoyl peroxide plus Adapalene in Acne Vulgaris, sponsored by Allergan. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2012-07-27.
Sponsored by Allergan · Phase 4, Interventional, and Treatment
A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 286 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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.
Time frame: Baseline, Week 12
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.
Time frame: Baseline, Week 12
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.
Time frame: Baseline, Week 12
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).
Time frame: Baseline, Week 12
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).
Time frame: Baseline, Week 12
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).
Time frame: Baseline, Week 12
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.
Time frame: Baseline, Week 12
| Milestone | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel |
|---|---|---|
| Started | 145 | 141 |
| Completed | 126 | 120 |
| Not completed | 19 | 21 |
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.
| Score on a scale | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel |
|---|---|---|
| Baseline | 2.80 ± 0.51 | 2.84 ± 0.45 |
| Change from baseline at Week 12 | -0.87 ± 0.82 | -1.27 ± 0.82 |
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.
| Percentage of participants | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel |
|---|---|---|
| Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity | 83.5 | 92.4 |
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 | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel |
|---|---|---|
| Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | -70.7 (-100.0 to 38.1) | -75.9 (-100.0 to -17.4) |
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 | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel |
|---|---|---|
| Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 | -55.3 (-100.0 to 115.0) | -60.7 (-100.0 to 31.6) |
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).
| Percent change | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel |
|---|---|---|
| Percent Change From Baseline in Total Lesion Count at Week 12 | -62.7 ± 27.0 | -65.0 ± 22.5 |
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.
| Percentage of participants | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel |
|---|---|---|
| Dryness | 21.3 | 11.9 |
| Peeling | 11.5 | 9.3 |
| Oiliness | 6.7 | 6.0 |
| Erythema | 8.2 | 6.8 |
| Pruritus | 12.4 | 8.5 |
| Burning | 13.2 | 12.7 |
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.
| Percentage of participants | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel |
|---|---|---|
| Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12 | 69.7 | 81.4 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aczone® Gel 5% Plus Differin® 0.3% Gel | — | 0/136 (0%) | 23/136 (16.9%) |
| Duac® Topical Gel Plus Differin® 0.3% Gel | — | 0/135 (0%) | 15/135 (11.1%) |
| Event | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel |
|---|---|---|
| NasopharyngitisInfections and infestations | 15/136 | 7/135 |
| HeadacheNervous system disorders | 8/136 | 8/135 |
| Age Continuous(Years) | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel | Total |
|---|---|---|---|
| Mean | 27.2 ± 6.5 | 27.9 ± 7.1 | 27.6 ± 6.8 |
| Sex: Female, Male(Participants) | Aczone® Gel 5% Plus Differin® 0.3% Gel | Duac® Topical Gel Plus Differin® 0.3% Gel | Total |
|---|---|---|---|
| Female | 145 | 141 | 286 |
| Male | 0 | 0 | 0 |
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