Acne Vulgaris
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.
Interventions
Once a day for 16 weeks
Once a day for 16 weeks
DRUGPlacebo
Once a day for 16 weeks
Sponsors
Dow Pharmaceutical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of acne vulgaris on the face and neck/trunk * Presence of inflammatory and non-inflammatory lesions on the face
Exclusion criteria
* Presence of any skin condition on the face that could interfere with clinical evaluations * Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit * Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit * Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the number of inflammatory lesions | Baseline and 22 weeks |
| Percent of patients who achieve success for the acne global severity score | Baseline and 22 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the number of non-inflammatory lesions | Baseline and 22 weeks |
Countries
Canada, United States
Outcome results
None listed