Efficacy and safety of CD5789 in skin keratinization disorders
- Conditions
- amellar IchthyosisMedDRA version: 16.0Level: LLTClassification code 10023686Term: Lamellar ichthyosisSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2013-001796-20-DE
- Lead Sponsor
- Galderma R&D SNC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
- Male or female subjects aged from 18 to 70 years old.
- Subjects with a clinical diagnosis of Lamellar Ichthyosis, based on clinical signs and, if possible, supported by genotyping.
- The subject has a similar Investigator Global Assessment score on right and left limbs of at least 2 (moderate).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
The subject has a significant concomitant disease other than the Lamellar Ichthyosis, which may put him/her at risk if he/she takes part in the study, and/or which may interfere with the study efficacy or safety assessments.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method