Efficacy and safety of CD5789 in skin keratinization disorders

Efficacy, safety and pharmacokinetics of 2 concentrations and 2 dosage regimens of CD5789 in subjects with Lamellar Ichthyosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001796-20-SE

Enrollment

Registered

2013-07-23

Start date

2013-12-17

Completion date

Unknown

Last updated

2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lamellar Ichthyosis MedDRA version: 16.1 Level: LLT Classification code 10023686 Term: Lamellar ichthyosis System Organ Class: 100000004850

Interventions

Product Code: CD5789 Pharmaceutical Form: Cream INN or Proposed INN: NA CAS Number: 895542-09-3 Current Sponsor code: CD5789 Other descriptive name: CD5789 cream (HE1 Concept) Concentration type: equa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate, in subjects who are currently under oral retinoid or not, the efficacy of: - CD5789 cream at 200 and 400 µg/g as compared with placebo after 6 weeks of once daily application. - 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: - 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. - 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).	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate, in subjects who are currently under oral retinoid or not, the efficacy of: - CD5789 cream at 200 and 400 µg/g as compared with placebo after 6 weeks of once daily application. - 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: - 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. - 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).

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Secondary

Measure	Time frame
Secondary end point(s): 1. Individual scaling and roughness scores 2. Response rate 3. Investigator Global Assessment (IGA) 4. Investigator’s and subject’s comparative evaluations 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). 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. 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). 4. at Day 40 (or earlier in case of study discontinuation). 5. at Day 40 (or earlier in case of study discontinuation)	—

Measure

Time frame

Secondary end point(s): 1. Individual scaling and roughness scores 2. Response rate 3. Investigator Global Assessment (IGA) 4. Investigator’s and subject’s comparative evaluations 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). 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. 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). 4. at Day 40 (or earlier in case of study discontinuation). 5. at Day 40 (or earlier in case of study discontinuation)

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Countries

Germany, Israel, Sweden, United States

Contacts

Public ContactCTA Coordinator

Galderma R&D SNC

cta.coordinator@galderma.com+33(0)493-95-70-85

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026