Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||12 Years and Over|
1. For Cohort A: subject is ≥18 years old; for Cohort B: subject is ≥12 years old. 2. Subject has known diagnosis of LI. 3. Subject has moderate to severe (IGA 3-4) LI on the IGA of LI severity. 4. Subject has signed an ICF at Screening before any investigational procedures. Subjects <18 years of age (or Age of Majority) must sign an assent form in conjunction with an ICF signed by the parent/legal representative. 5. Subject who is participating in optional photography has signed a photography ICF. 6. Subject who is participating in the optional PK substudy has signed a PK ICF. Minors, in the event of their reaching majority during the study, should be capable of giving consent to take part in the PK substudy. 7. Subject is not of childbearing potential, who is postmenopausal (absence of menstrual bleeding for 1 year before Baseline, without any other medical reason), or has documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. For individuals with permanent infertility due to an alternate medical cause other than the above, (e.g., Mullerian agenesis, androgen insensitivity), investigator discretion should be applied to determining study entry. OR.
- - Subject is a woman of childbearing potential (WOCBP), i.e., a female ≥12 years of age (regardless of whether they have experienced/reported menarche), or a male subject with sexual partners capable of reproduction who agrees to use 2 effective forms of contraception during the study and for at least 1 month after the last study drug application.
- - bilateral tubal ligation.
- - combined oral contraceptives (estrogens and progesterone), vaginal ring, or implanted or injectable hormonal contraceptives with a stable dose for at least 1 month before Baseline; hormonal contraceptives must inhibit ovulation.
- - intrauterine device (IUD) inserted at least 1 month before Baseline OR Agrees to abstain from heterosexual intercourse during study participation and for 1 month after the last application of study drug and to use a highly effective contraceptive as backup if he or she becomes sexually active during the study.
Exclusion criteria:1. Subject has any variant of ichthyosis other than LI or another disorder of keratinization, including syndromic ichthyoses. 2. Subject has current moderate or severe stinging/burning at Screening. 3. 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. 4. 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. 5. Subject was previously treated with trifarotene/CD5789 in an acne or ichthyosis study. 6. 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. 7. 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. 8. 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. 9. Subject with positive serology for hepatitis B surface antigen, hepatitis C, or are known to be HIV positive or to have AIDS at Screening. 10. Subject with any of the following laboratory values at Screening: 1. Aspartate aminotransferase or alanine aminotransferase >1.5 × upper limit of normal defined by the laboratory. 2. Total bilirubin >1.25 × ULN at Screening. Subjects with known Gilbert's syndrome may be included with total bilirubin >1.25 × ULN. 3. Hemoglobin <12.5 g/dL for men and <11.5 g/dL for women. 4. Platelets <150 × 109/L or >400 × 109/L. 11. 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. 12. 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. 13. 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. 14. Subject has a known allergy or sensitivity to any of the components of the investigational products. 15. 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.). 16. Subject is inherently sensitive to sunlight. 17. Subject is unable or unwilling to stop use of topical or systemic retinoids. 18. Subject is presumed to be abusing drug or alcohol at Screening or Baseline Visits based on medical history or current clinical symptoms. 19. Subject is participating in another interventional clinical trial. 20. Subject is institutionalized. 21. Subject is in any way related to the sponsor, investigator, or site personnel.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Mayne Pharma International Pty Ltd|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Keith A. Choate, MD|
|Principal Investigator Affiliation||Yale University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Canada, France, Germany, Israel, Spain, Ukraine, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
This is a 2-cohort, multicenter study in subjects with moderate to severe LI. Adults (Cohort A) and adults and adolescents (Cohort B) will be randomized in a double-blind fashion to 1 of 2 doses of active or vehicle and treated twice weekly for 90 days. Subjects who complete the randomized, double-blind portion of the study will be eligible to enter a 90 day, open-label extension study. Approximately 15 adults (≥18 years old) will be randomized into the first cohort of subjects (Cohort A) in a 1:1:1 ratio and treated twice weekly for up to 90 days. If no safety issues are identified, both adults and adolescents (ages 12-17 years, inclusive) will be allowed to enroll in Cohort B. Subjects in Cohort B will be randomized 1:1:1 and treated twice weekly for up to 90 days in the same manner as subjects in Cohort A. All subjects who complete 90 days of double-blind study treatment will be eligible to enroll in a 90 open-label extension. Subjects in the open-label extension will receive active twice weekly for up to 90 days.
Experimental: CD5789 Cream 200 µg/g
CD5789 200 µg/g, topical, 50g
Experimental: CD5789 Cream 100 µg/g
CD5789 100 µg/g, topical, 50g
Placebo Comparator: CD5789 Cream Vehicle
CD5789 Cream Vehicle, topical, 50g
Drug: - CD5789 Cream 200 µg/g
A fixed dose (determined at Visit 1) of 200 µg/g applied topically twice weekly to up to 90% BSA
Drug: - CD5789 Cream 100 µg/g
A fixed dose (determined at Visit 1) of 100 µg/g applied topically twice weekly to up to 90% BSA
Drug: - CD5789 Cream Vehicle
A fixed dose (determined at Visit 1) applied topically twice weekly, up to 36 g per dose up to 90% BSA
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.