Overview

Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
Summary
Therapeutic equivalence and safety study
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Taro Pharmaceuticals USA
Treatments:
Dapsone
Criteria
Inclusion Criteria:

- Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis
of acne vulgaris

- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3,
or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below)

Exclusion Criteria:

- Female Subjects who are pregnant, nursing or planning to become pregnant during study
participation.