Healthy Volunteers
Conditions
Brief summary
This study will evaluate the potential of dapsone gel and its vehicle to cause a photoallergic reaction after repeated application and irradiation to the skin of healthy volunteers under controlled conditions.
Interventions
DRUGdapsone gel
Patches containing dapsone gel will be applied to the skin.
Patches containing dapsone gel vehicle will be applied to the skin.
Sponsors
Allergan
Almirall, S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
-Healthy adults.
Exclusion criteria
* Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application * Sensitivity to adhesive bandages or tape.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Photoallergic (Sensitizing) Potential Using a Visual Scale | Week 6 |
Countries
United States
Outcome results
None listed