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

Stopped early · Phase 2

Conditions studied: Lamellar Ichthyosis

In brief

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.

Key facts

Study ID

NCT03738800

Run by

Mayne Pharma International Pty Ltd

People needed

65

Starts

2019-05-01

Expected to finish

2021-09-03

Last updated by the study team

2023-08-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Subject has an ongoing cutaneous infection or any other significant concomitant skin disease (other than the LI) which, in the investigator's opinion, may interfere with the study assessments.
• Subject with fasting triglycerides >200 mg/dL or >2.25 mmol/L and/or total cholesterol >250 mg/dL or >6.5 mmol/L. Subjects whose triglycerides and/or total cholesterol are within normal limits with a stable dose of lipid-lowering agents for at least 6 months may be included.
• Subject was previously treated with trifarotene/CD5789 in an acne or ichthyosis study.
• Subject has any other significant concomitant disease, or poorly controlled medical condition other than LI that in the investigator's opinion may put him or her at risk if he or she takes part in the study, and/or that may interfere with the study assessments.
• Subject has a medical condition that potentially alters bone metabolism (e.g., osteoporosis, thyroid dysfunction, Cushing syndrome, Crohn's disease, or ulcerative colitis). Subjects with hypothyroidism who are on a stable dose of thyroid hormone replacement therapy and whose thyroid-stimulating hormone (TSH) is normal may be included
• Subject is being treated for major depression disorder and/or has a history of major depression or suicide attempt requiring hospitalization, medications, and close psychiatric surveillance to prevent suicide attempts.
• Subject with positive serology for hepatitis B surface antigen, hepatitis C, or are known to be HIV positive or to have AIDS at Screening.
• Subject with any of the following laboratory values at Screening:
• Aspartate aminotransferase or alanine aminotransferase >1.5 × upper limit of normal defined by the laboratory
• Total bilirubin >1.25 × ULN at Screening. Subjects with known Gilbert's syndrome may be included with total bilirubin >1.25 × ULN
• Hemoglobin <12.5 g/dL for men and <11.5 g/dL for women
• Platelets <150 × 109/L or >400 × 109/L.
• Subject has any clinically other significant abnormal laboratory value (hematology, chemistry, or urinalysis) at Screening that, in the investigator's opinion, may put the subject at risk if he or she takes part in the study, and/or that may interfere with the study assessments.
• Subject has had recent systemic malignancy (e.g., within 5 years) with exception of nonmelanoma skin cancer or cervical intraepithelial neoplasia of Grade 1 who are >6 months post-treatment.
• Subject has a history of long QT syndrome or has clinically significant electrocardiogram (ECG) abnormalities, including clinically significant conduction disorders or significant arrhythmias, or QTcF interval >450 ms.
• Subject has a known allergy or sensitivity to any of the components of the investigational products.
• Subject has been exposed to excessive UV radiations on the treated zones within 1 month before Baseline visit or is planning intensive UV exposure during the study (e.g., occupational exposure to the sun, sunbathing, phototherapy, etc.).
• Subject is inherently sensitive to sunlight.
• Subject is unable or unwilling to stop use of topical or systemic retinoids.
• Subject is presumed to be abusing drug or alcohol at Screening or Baseline Visits based on medical history or current clinical symptoms.
• Subject is participating in another interventional clinical trial.
• Subject is institutionalized.
• Subject is in any way related to the sponsor, investigator, or site personnel.

Where it is running

• TCR Medical Corporation — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• NorthShore University HealthSystem — Skokie, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• DermAssociates, PC — Rockville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
• Eastern Health Monash University — Box Hill, Australia
• Veracity Clinical Research — Brisbane, Australia
• Royal Children's Hospital — Parkville, Australia
• Premier Specialists Ptd Ltd — Sydney, Australia
• The Hospital for Sick Children — Toronto, Canada
• Dermatologie pédiatrique — Paris, France
• CHU Charles Nicolle — Rouen, France
• CHU de Toulouse- Hospital Larrey — Toulouse, France
• Charite - Universitaetsmedizin Berlin — Berlin, Germany
• Universitätsklinkum Frankfurt — Frankfurt, Germany
• Kath. Kinderkrankenhaus Wilhelmstift — Hamburg, Germany
• Ludwig-Maximilians University — Munich, Germany
• Universitatsmedizin Rostock — Rostock, Germany
• Tel Aviv Sourasky Mc — Tel Aviv, Israel
• Hospital Clinic de Barcelona — Barcelona, Spain

Full record on ClinicalTrials.gov

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