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This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapsone Formulation A | Experimental | Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
|
| Dapsone Formulation B | Experimental | Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
|
| Dapsone Formulation C | Experimental | Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
|
| Dapsone 5% Gel | Active Comparator | Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapsone Formulation A | Drug | Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Level (Cmax) of Dapsone | Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Level (Cmax) of Dapsone Metabolites | Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. The dapsone metabolites are N-acetyl dapsone and dapsone hydroxylamine. | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College Station | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27741344 | Background | Jarratt MT, Jones TM, Chang-Lin JE, Tong W, Berk DR, Lin V, Kaoukhov A. Safety and Pharmacokinetics of Once-Daily Dapsone Gel, 7.5% in Patients With Moderate Acne Vulgaris. J Drugs Dermatol. 2016 Oct 1;15(10):1250-1259. |
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The protocol was amended mid-study to exclude patients <16 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapsone Formulation A | Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| FG001 | Dapsone Formulation B | Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| FG002 | Dapsone Formulation C | Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| FG003 | Dapsone 5% Gel | Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapsone Formulation A | Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| BG001 | Dapsone Formulation B | Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| 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 | Maximum Plasma Level (Cmax) of Dapsone | Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. | All treated subjects with data for this time point | Posted | Mean | Standard Deviation | Nanograms/Milliliter (ng/mL) | Day 28 |
|
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The Safety Population consisted of all subjects who received at least 1 dose of study medication. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dapsone Formulation A | Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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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, upper chest, upper back, and shoulders for 28 days. |
|
| Dapsone Formulation C | Drug | Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
|
| Dapsone 5% Gel | Drug | Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. |
|
|
| BG002 | Dapsone Formulation C | Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| BG003 | Dapsone 5% Gel | Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Dapsone Formulation C | Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. |
| OG003 | Dapsone 5% Gel | Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. |
|
|
| Secondary | Maximum Plasma Level (Cmax) of Dapsone Metabolites | Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. The dapsone metabolites are N-acetyl dapsone and dapsone hydroxylamine. | All treated subjects with data for this time point | Posted | Mean | Standard Deviation | Nanograms/Milliliter (ng/mL) | Day 28 |
|
|
|
| 0 |
| 20 |
| 20 |
| 20 |
| EG001 | Dapsone Formulation B | Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. | 0 | 19 | 16 | 19 |
| EG002 | Dapsone Formulation C | Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. | 0 | 19 | 10 | 19 |
| EG003 | Dapsone 5% Gel | Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. | 0 | 19 | 11 | 19 |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA version 16.0 | Non-systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA version 16.0 | Non-systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA version 16.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Medical Device Pain | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Tinea Versicolour | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
|
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
|
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.
| D045424 |
| Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| Dapsone Hydroxylamine |
|