Efficacy and safety of CD5789 in skin keratinization disorders
- Conditions
- amellar IchthyosisMedDRA version: 16.1Level: LLTClassification code 10023686Term: Lamellar ichthyosisSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2013-001796-20-SE
- 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 Main Objective: The primary objective of this study is to evaluate, in subjects who are currently under oral retinoid or not, the efficacy of:<br>- CD5789 cream at 200 and 400 µg/g as compared with placebo after 6 weeks of once daily application.<br>- CD5789 cream at 400 µg/g as compared with placebo after 6 weeks of twice-weekly applications on 2 consecutive days.;Secondary Objective: The secondary objectives are to assess, in subjects who are currently under oral retinoid or not:<br>- the local tolerability and systemic safety of CD5789 cream at 200 and 400 µg/g applied once daily during 6 weeks, and 400 µg/g applied twice weekly on two consecutive days during 6 weeks.<br>- the plasma and cutaneous levels of CD5789 cream at 200 and 400 µg/g over the different dosage regimens.;Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: at Day 40 (or earlier in case of study discontinuation).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Individual scaling and roughness scores <br><br>2. Response rate<br><br>3. Investigator Global Assessment (IGA)<br><br>4. Investigator’s and subject’s comparative evaluations<br><br>5. Subject’s acceptability questionnaire ;Timepoint(s) of evaluation of this end point: 1. at Screening, Day 1, Day 8±2, Day 15±2, Day 22±2, Day 29±2, Day 40 and Day 68±2 (or earlier in case of study discontinuation).<br><br>2. with response defined as Scaling = 0 or 1 at day 40 and improved by at least 2 grades, and roughness = 0 or 1 at day 40.<br><br>3. at Screening, Day 1, Day 8±2, Day 15±2, Day 22±2, Day 29±2, Day 40 and Day 68±2 (or earlier in case of study discontinuation).<br><br>4. at Day 40 (or earlier in case of study discontinuation).<br><br>5. at Day 40 (or earlier in case of study discontinuation)