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Study was never initiated due to company decision. No study subjects were ever enrolled or dosed.
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This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapsone Formulation A | Experimental | Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
|
| Dapsone Formulation B | Experimental | Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
|
| Dapsone Formulation C | Experimental | Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
|
| Dapsone 5% Gel | Active Comparator | Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapsone Formulation A | Drug | Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Inflammatory Lesion Count | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Non-Inflammatory Lesion Count | Baseline, Week 12 | |
| Change from Baseline in Total Lesion Count | Baseline, Week 12 | |
| Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D003622 | Dapsone |
| D005782 | Gels |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D003102 | Colloids |
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| Dapsone Formulation B | Drug | Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
|
| Dapsone Formulation C | Drug | Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
|
| Dapsone 5% Gel | Drug | Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. |
|
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| Week 12 |
| D045424 |
| Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |