Acne Vulgaris
Conditions
Brief summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.
Interventions
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
DRUGDapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of acne vulgaris * Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study * If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the duration of the study * willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip makeup), and chemical peels throughout the study
Exclusion criteria
* Oral acne treatments within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Level (Cmax) of Dapsone | Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Level (Cmax) of Dapsone Metabolites | Day 28 | 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. |
Countries
United States
Participant flow
Pre-assignment details
The protocol was amended mid-study to exclude patients \<16 years.
Participants by arm
| Arm | Count |
|---|---|
| Dapsone Formulation A Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days. | 20 |
| Dapsone Formulation B Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days. | 19 |
| Dapsone Formulation C Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days. | 19 |
| Dapsone 5% Gel Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days. | 19 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Due to amended age eligibility criteria | 3 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Dapsone Formulation A | Dapsone Formulation B | Dapsone Formulation C | Dapsone 5% Gel | Total |
|---|---|---|---|---|---|
| Age, Customized 12 to 17 years | 8 Participants | 7 Participants | 7 Participants | 7 Participants | 29 Participants |
| Age, Customized 18 to 35 years | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 48 Participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 10 Participants | 9 Participants | 36 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 9 Participants | 10 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 20 | 16 / 19 | 10 / 19 | 11 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 0 / 19 | 0 / 19 |
Outcome results
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.
Time frame: Day 28
Population: All treated subjects with data for this time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dapsone Formulation A | Maximum Plasma Level (Cmax) of Dapsone | 11.7 Nanograms/Milliliter (ng/mL) | Standard Deviation 5.5 |
| Dapsone Formulation B | Maximum Plasma Level (Cmax) of Dapsone | 14.1 Nanograms/Milliliter (ng/mL) | Standard Deviation 8.8 |
| Dapsone Formulation C | Maximum Plasma Level (Cmax) of Dapsone | 13.0 Nanograms/Milliliter (ng/mL) | Standard Deviation 6.8 |
| Dapsone 5% Gel | Maximum Plasma Level (Cmax) of Dapsone | 17.6 Nanograms/Milliliter (ng/mL) | Standard Deviation 6.7 |
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.
Time frame: Day 28
Population: All treated subjects with data for this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dapsone Formulation A | Maximum Plasma Level (Cmax) of Dapsone Metabolites | N-Acetyl Dapsone | 5.44 Nanograms/Milliliter (ng/mL) | Standard Deviation 4.25 |
| Dapsone Formulation A | Maximum Plasma Level (Cmax) of Dapsone Metabolites | Dapsone Hydroxylamine | 0.908 Nanograms/Milliliter (ng/mL) | Standard Deviation 0.433 |
| Dapsone Formulation B | Maximum Plasma Level (Cmax) of Dapsone Metabolites | Dapsone Hydroxylamine | 1.11 Nanograms/Milliliter (ng/mL) | Standard Deviation 0.46 |
| Dapsone Formulation B | Maximum Plasma Level (Cmax) of Dapsone Metabolites | N-Acetyl Dapsone | 6.00 Nanograms/Milliliter (ng/mL) | Standard Deviation 3.85 |
| Dapsone Formulation C | Maximum Plasma Level (Cmax) of Dapsone Metabolites | N-Acetyl Dapsone | 6.47 Nanograms/Milliliter (ng/mL) | Standard Deviation 5.43 |
| Dapsone Formulation C | Maximum Plasma Level (Cmax) of Dapsone Metabolites | Dapsone Hydroxylamine | 1.19 Nanograms/Milliliter (ng/mL) | Standard Deviation 0.76 |
| Dapsone 5% Gel | Maximum Plasma Level (Cmax) of Dapsone Metabolites | N-Acetyl Dapsone | 11.7 Nanograms/Milliliter (ng/mL) | Standard Deviation 8.8 |
| Dapsone 5% Gel | Maximum Plasma Level (Cmax) of Dapsone Metabolites | Dapsone Hydroxylamine | 1.47 Nanograms/Milliliter (ng/mL) | Standard Deviation 0.56 |