Acne Vulgaris
Conditions
Brief summary
This study will evaluate the effect of dapsone gel in female subjects with skin of color (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.
Interventions
DRUGDapsone Gel
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of acne vulgaris * Medium to dark complexion (Fitzpatrick Skin Type IV, V or VI) * Willing to avoid excessive or prolonged exposure of the face to ultraviolet light (eg, sunlight, tanning beds) throughout the study
Exclusion criteria
* Received treatment with botulinum toxin of any serotype in the face within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician | Baseline, Week 12 | The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Lesion Counts | Baseline, Weeks 2, 6 and 12 | The investigator evaluated Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement). |
| Percent Change From Baseline in Inflammatory Lesion Counts | Baseline, Weeks 2, 6 and 12 | The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement). |
| Percent Change From Baseline in Non-Inflammatory Lesion Counts | Baseline, Weeks 2, 6 and 12 | The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement). |
| Change From Baseline in the GAAS | Baseline, Weeks 2 and 6 | The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement. |
| Acne Symptom and Impact Scale (ASIS) Sign Domain Score | Weeks 2, 6 and 12 | The participant assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. Higher scores indicate the presence of more severe signs of acne. |
| ASIS Impact Domain Score | Weeks 2, 6 and 12 | The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance. |
| Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS | Weeks 2, 6 and 12 | The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. The percentage of participants with a score of 0=none or 1=minimal is reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dapsone Gel Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks. | 67 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other Miscellaneous Reasons | 2 |
| Overall Study | Pregnancy | 1 |
Baseline characteristics
| Characteristic | Dapsone Gel |
|---|---|
| Age, Customized 18 to <30 years | 32 participants |
| Age, Customized ≥30 to <50 years | 32 participants |
| Age, Customized ≥50 years | 3 participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 68 |
| serious Total, serious adverse events | 1 / 68 |
Outcome results
Primary
Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician
The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.
Time frame: Baseline, Week 12
Population: Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapsone Gel | Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician | Baseline | 2.8 score on a scale | Standard Deviation 0.72 |
| Dapsone Gel | Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician | Change from Baseline at Week 12 | -1.2 score on a scale | Standard Deviation 0.88 |
Secondary
Acne Symptom and Impact Scale (ASIS) Sign Domain Score
The participant assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. Higher scores indicate the presence of more severe signs of acne.
Time frame: Weeks 2, 6 and 12
Population: Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapsone Gel | Acne Symptom and Impact Scale (ASIS) Sign Domain Score | Week 2 | 1.7 score on a scale | Standard Deviation 0.72 |
| Dapsone Gel | Acne Symptom and Impact Scale (ASIS) Sign Domain Score | Week 6 (n=60) | 1.3 score on a scale | Standard Deviation 0.68 |
| Dapsone Gel | Acne Symptom and Impact Scale (ASIS) Sign Domain Score | Week 12 (n=63) | 1.1 score on a scale | Standard Deviation 0.67 |
Secondary
ASIS Impact Domain Score
The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance.
Time frame: Weeks 2, 6 and 12
Population: Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapsone Gel | ASIS Impact Domain Score | Week 2 | 1.6 score on a scale | Standard Deviation 0.91 |
| Dapsone Gel | ASIS Impact Domain Score | Week 6 (n=60) | 1.3 score on a scale | Standard Deviation 0.91 |
| Dapsone Gel | ASIS Impact Domain Score | Week 12 (n=63) | 1.1 score on a scale | Standard Deviation 0.91 |
Secondary
Change From Baseline in the GAAS
The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.
Time frame: Baseline, Weeks 2 and 6
Population: Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapsone Gel | Change From Baseline in the GAAS | Baseline | 2.8 score on a scale | Standard Deviation 0.72 |
| Dapsone Gel | Change From Baseline in the GAAS | Change from Baseline at Week 2 | -0.3 score on a scale | Standard Deviation 0.63 |
| Dapsone Gel | Change From Baseline in the GAAS | Change from Baseline at Week 6 | -0.6 score on a scale | Standard Deviation 0.74 |
Secondary
Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS
The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. The percentage of participants with a score of 0=none or 1=minimal is reported.
Time frame: Weeks 2, 6 and 12
Population: Participants from the mITT, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dapsone Gel | Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS | Week 2 | 6.0 percentage of participants |
| Dapsone Gel | Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS | Week 6 (n=61) | 13.1 percentage of participants |
| Dapsone Gel | Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS | Week 12 (n=63) | 42.9 percentage of participants |
Secondary
Percent Change From Baseline in Inflammatory Lesion Counts
The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).
Time frame: Baseline, Weeks 2, 6 and 12
Population: Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapsone Gel | Percent Change From Baseline in Inflammatory Lesion Counts | Change from Baseline at Week 2 | -25.0 percent change | Standard Deviation 32.01 |
| Dapsone Gel | Percent Change From Baseline in Inflammatory Lesion Counts | Change from Baseline at Week 6 (n=61) | -48.0 percent change | Standard Deviation 26.72 |
| Dapsone Gel | Percent Change From Baseline in Inflammatory Lesion Counts | Change from Baseline at Week 12 (n=63) | -65.0 percent change | Standard Deviation 23.31 |
Secondary
Percent Change From Baseline in Non-Inflammatory Lesion Counts
The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).
Time frame: Baseline, Weeks 2, 6 and 12
Population: Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapsone Gel | Percent Change From Baseline in Non-Inflammatory Lesion Counts | Change from Baseline at Week 2 | -9.8 percent change | Standard Deviation 32.03 |
| Dapsone Gel | Percent Change From Baseline in Non-Inflammatory Lesion Counts | Change from Baseline at Week 6 (n=61) | -16.0 percent change | Standard Deviation 36.19 |
| Dapsone Gel | Percent Change From Baseline in Non-Inflammatory Lesion Counts | Change from Baseline at Week 12 (n=63) | -41.0 percent change | Standard Deviation 34.15 |
Secondary
Percent Change From Baseline in Total Lesion Counts
The investigator evaluated Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement).
Time frame: Baseline, Weeks 2, 6 and 12
Population: Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapsone Gel | Percent Change From Baseline in Total Lesion Counts | Change from Baseline at Week 2 | -16.0 percent change | Standard Deviation 23.45 |
| Dapsone Gel | Percent Change From Baseline in Total Lesion Counts | Change from Baseline at Week 6 (n=61) | -30.0 percent change | Standard Deviation 26.15 |
| Dapsone Gel | Percent Change From Baseline in Total Lesion Counts | Change from Baseline at Week 12 (n=63) | -52.0 percent change | Standard Deviation 26.96 |