A Safety Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis
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- STATUS
- Recruiting
-
- participants needed
- 120
-
- sponsor
- Mayne Pharma International Pty Ltd
Phoevos Hughes, JD
Primary Contact
Premier Specialists Ptd Ltd (7.3 mi away) Contact
+26 other locationSummary
This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 12-week, safety, efficacy, and systemic exposure study followed by a 12-week open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale
Description
This is a 2-cohort, multicenter study in subjects with moderate to severe LI. Adults (Cohort
- and adults and adolescents (Cohort B) will be randomized in a double-blind fashion to 1 of 2 doses of active or vehicle and treated twice weekly for 12 weeks. Subjects who complete the randomized, double-blind portion of the study will be eligible to enter a 12 week, open-label extension study.
Approximately 15 adults (18 years old) will be randomized into the first cohort of subjects (Cohort A) in a 1:1:1 ratio and treated twice weekly for up to 12 weeks. If no safety issues are identified, both adults and adolescents (ages 12-17 years, inclusive) will be allowed to enroll in Cohort B. Subjects in Cohort B will be randomized 1:1:1 and treated twice weekly for up to 12 weeks in the same manner as subjects in Cohort A.
All subjects who complete 12 weeks of double-blind study treatment will be eligible to enroll in a 12-week open-label extension. Subjects in the open-label extension will receive active twice weekly for up to 12 weeks.
Details
| Treatment | CD5789 Cream 200 µg/g, CD5789 Cream 100 µg/g, CD5789 Cream Vehicle |
|---|---|
| Clinical Study Identifier | NCT03738800 |
| Sponsor | Mayne Pharma International Pty Ltd |
| Last Modified on | 23 January 2021 |
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