P3 Long Term Safety Study of Once Daily SB204 in Acne
Status: | Completed |
---|---|
Conditions: | Acne, Acne, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 9 - 99 |
Updated: | 1/13/2019 |
Start Date: | May 12, 2016 |
End Date: | April 27, 2017 |
A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris
This is a multi-center, open label long-term safety (LTS) study to be conducted in
approximately 600 subjects with acne vulgaris.
approximately 600 subjects with acne vulgaris.
A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily
in the Treatment of Acne Vulgaris.
in the Treatment of Acne Vulgaris.
Inclusion Criteria:
- Have completed 12 weeks of treatment in NI-AC301 or NI-AC302
Exclusion Criteria:
- Terminated early from an SB204 Phase 3 pivotal study for any reason
- Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants
stopping study drug application
- Have used medications or vitamins during the 12 weeks immediately preceding this study
which were reported to exacerbate acne.
We found this trial at
69
sites
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