Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study was never initiated due to company decision. No study subjects were ever enrolled or dosed.
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 investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Combination dapsone/adapalene Formulation A Gel | Experimental | Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. |
|
| Fixed Combination dapsone/adapalene Formulation B Gel | Experimental | Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. |
|
| dapsone 5% gel (ACZONE®) | Active Comparator | Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders. |
|
| adapalene 0.3% gel (Differin®) | Active Comparator | Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed Combination dapsone/adapalene Formulation A Gel | Drug | Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Levels of Dapsone | Day 1 | |
| Plasma Levels of Dapsone | Day 14 | |
| Plasma Levels of Adapalene | Day 1 | |
| Plasma Levels of Adapalene | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Local Dermal Tolerability Rating Using a 4-Point Scale | Day 14 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
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 |
| D005782 | Gels |
| D000068816 | Adapalene |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D003102 | Colloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fixed Combination dapsone/adapalene Formulation B Gel | Drug | Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. |
|
| dapsone 5% gel | Drug | Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders. |
|
|
| adapalene 0.3% gel | Drug | Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. |
|
|
| D045424 |
| Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |