P3 Study in Acne Comparing Once Daily SB204 and Vehicle
Status: | Completed |
---|---|
Conditions: | Acne, Acne, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 9 - 99 |
Updated: | 11/21/2018 |
Start Date: | February 22, 2016 |
End Date: | December 21, 2016 |
A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris
This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel
group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
This is a double-blind, placebo controlled study in subjects with moderate to severe acne.
Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD
in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and
inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline
evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).
Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD
in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and
inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline
evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).
Inclusion Criteria:
- Moderate to severe acne
- Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones)
on the face
- Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)
Exclusion Criteria:
- Women of child-bearing potential who are pregnant, nursing, considering becoming
pregnant
- Any dermatologic condition that could interfere with clinical evaluations including
severe, recalcitrant cystic acne
We found this trial at
55
sites
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