Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapsone Gel | Experimental | Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapsone Gel | Drug | Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington D.C. | District of Columbia | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dapsone Gel | Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Modified Intent-to treat population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dapsone Gel | Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dapsone Gel | Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spontaneous abortion | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003622 | Dapsone |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, Weeks 2 and 6 |
| 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). | Baseline, Weeks 2, 6 and 12 |
| 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). | Baseline, Weeks 2, 6 and 12 |
| 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). | Baseline, Weeks 2, 6 and 12 |
| 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. | Weeks 2, 6 and 12 |
| 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. | Weeks 2, 6 and 12 |
| 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. | Weeks 2, 6 and 12 |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 2 and 6 |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Weeks 2, 6 and 12 |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Weeks 2, 6 and 12 |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Weeks 2, 6 and 12 |
|
|
|
| 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. | 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. | Posted | Number | percentage of participants | Weeks 2, 6 and 12 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Weeks 2, 6 and 12 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Weeks 2, 6 and 12 |
|
|
|
| 1 |
| 68 |
| 0 |
| 68 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Measurements |
|---|---|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|