Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
| Status: | Completed |
|---|---|
| Conditions: | Acne, Acne, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 12 - 40 |
| Updated: | 5/5/2017 |
| Start Date: | April 2014 |
| End Date: | June 2016 |
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Test Gel, 5% to ACZONE Gel, 5% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris
Therapeutic equivalence and safety study
To evaluate the therapeutic equivalence and safety of Test formulation and marketed
Reference Listed Drug (RLD).
To demonstrate the superiority of efficacy of the Test and Reference products over the
placebo control in the treatment.
To compare the safety of Test, Reference and Placebo treatments.
Reference Listed Drug (RLD).
To demonstrate the superiority of efficacy of the Test and Reference products over the
placebo control in the treatment.
To compare the safety of Test, Reference and Placebo treatments.
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.
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