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A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis

NCT03738800 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-08-14

Study results available
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Summary

This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale.

Conditions

  • Lamellar Ichthyosis

Interventions

DRUG

CD5789 Cream 200 µg/g

A fixed dose (determined at Visit 1) of 200 µg/g applied topically twice weekly to up to 90% BSA

DRUG

CD5789 Cream 100 µg/g

A fixed dose (determined at Visit 1) of 100 µg/g applied topically twice weekly to up to 90% BSA

DRUG

CD5789 Cream Vehicle

A fixed dose (determined at Visit 1) applied topically twice weekly, up to 36 g per dose up to 90% BSA

Sponsors & Collaborators

  • Mayne Pharma International Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Keith A. Choate, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-09-03
Completion
2021-09-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Israel
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03738800 on ClinicalTrials.gov