Trials Sponsors Conditions Drugs Pricing

Conditions

Lamellar Ichthyosis

Outcome Measures

Primary Outcomes (1)

The Percentage of Subjects in Each Treatment Group Who Experienced Successful Resolution of LI.
The percentage of subjects in each treatment group who experienced successful resolution of LI where "success" is defined as clear/almost clear on treated areas and at least a 2-grade change from Baseline at Day 90/end-of-treatment (EOT) in the Double-blind Period on the 5-point IGA full body scale.
90 Days

Secondary Outcomes (6)

Total 16-point Visual Index for Ichthyosis Severity (VIIS)
90 Days
The Difference in Mean Scores Using Individual Score for Roughness
90 Days
The Difference in Mean Scores Using Palm Sole Assessment
90 Days
The Difference in Proportion of Subjects With Presence of Fissures on Palms Between the Active and Vehicle Groups
90 Days
Quality of Life Measurement Per Dermatology Life Quality Index (DLQI)
90 Days
+1 more secondary outcomes

Other Outcomes (10)

The Difference in Mean Ectropion Scores Between the Active and Vehicle Groups
180 Days
Quality of Life Measurement Per EQ-5D-5L
180 Days
Incidents of Adverse Events
180 Days
+7 more other outcomes

Study Arms (3)

CD5789 Cream 200 µg/g

EXPERIMENTAL

CD5789 200 µg/g, topical, 50g

Drug: CD5789 Cream 200 µg/g

CD5789 Cream 100 µg/g

EXPERIMENTAL

CD5789 100 µg/g, topical, 50g

Drug: CD5789 Cream 100 µg/g

CD5789 Cream Vehicle

PLACEBO COMPARATOR

CD5789 Cream Vehicle, topical, 50g

Drug: CD5789 Cream Vehicle

Interventions

CD5789 Cream 200 µg/gDrug

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

CD5789 Cream 200 µg/g

CD5789 Cream 100 µg/gDrug

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

CD5789 Cream 100 µg/g

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

Subject has any variant of ichthyosis other than LI or another disorder of keratinization, including syndromic ichthyoses.
Subject has current moderate or severe stinging/burning at Screening.

Sponsors & Collaborators

Mayne Pharma International Pty Ltd
Industrylead

Study Sites (36)

TCR Medical Corporation

San Diego, California, 92123, United States

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Yale University

New Haven, Connecticut, 06519, United States

NorthShore University HealthSystem

Skokie, Illinois, 60077, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

DermAssociates, PC

Rockville, Maryland, 20850, United States

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

MeSH Terms

Conditions

Ichthyosis, Lamellar

Interventions

trifarotene

Condition Hierarchy (Ancestors)

Ichthyosiform Erythroderma, CongenitalIchthyosisSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title: Mayne Pharma
Organization: Mayne Pharma

Study Officials

Keith A. Choate, MD
Yale University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

65 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

November 13, 2018

Study Start

May 1, 2019

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (10)

Study Arms (3)

CD5789 Cream 200 µg/g

CD5789 Cream 100 µg/g

CD5789 Cream Vehicle

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (36)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (10)

Study Arms (3)

CD5789 Cream 200 µg/g

CD5789 Cream 100 µg/g

CD5789 Cream Vehicle

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (36)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations