Acne Vulgaris
Conditions
Brief summary
To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.
Detailed description
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.
Interventions
DRUGDPSG 7.5%
topical gel
DRUGAczone
topical gel
DRUGPlacebo
topical gel
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris.
Exclusion criteria
* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in non-inflammatory lesion counts | 12 weeks | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts |
| Change in inflammatory lesion counts | 12 weeks | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response of success | 12 weeks | The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment |
Outcome results
None listed