Actively Recruiting
A Study to Investigate the Improvement of Photosensitivity in Terms of Skin Lesions Associated With CEP Following Administration of Oral ATL-001 (Ciclopirox Oral Solution) in Participants Aged >18 Years of Age With CEP
Led by Atlas Molecular Pharma · Updated on 2026-03-24
6
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a study to investigate the effect of oral ATL-001 (ciclopirox) in CEP (Congenital Erythropoietic Porphyria) patients. During the study, it will be measured the improvement of skin lesions, fatigue and other clinical symptoms as well as blood parameters. Funding source - FDA OOPD
CONDITIONS
Official Title
A Study to Investigate the Improvement of Photosensitivity in Terms of Skin Lesions Associated With CEP Following Administration of Oral ATL-001 (Ciclopirox Oral Solution) in Participants Aged >18 Years of Age With CEP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of signing the informed consent form
- Diagnosis of Congenital Erythropoietic Porphyria (CEP) based on medical history and/or biochemical porphyrin analysis, with Sponsor approval
- Female participants must not be pregnant or breastfeeding at screening or admission
- Female participants must be of nonchildbearing potential or agree to use two effective methods of contraception during the study and for 4 weeks after last dose, with negative pregnancy tests
- Male participants with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 4 weeks after last dose, and refrain from sperm donation during this time
- Negative pregnancy test for females of childbearing potential at screening, baseline, and every visit prior to dosing
- Ability to understand study aims, procedures, and requirements and provide written informed consent
- Ability to comply with all study procedures
- Ability and commitment to complete study diaries and questionnaires
You will not qualify if you...
- Presence of any inherited or acquired red cell disease causing anemia other than CEP
- Any other photodermatosis such as solar urticaria
- History or known allergic reaction to any excipients or the investigational drug
- Major surgery within 8 weeks before screening, incomplete recovery from previous surgery, or planned major surgery during the study
- History of alcohol dependence or excessive alcohol use
- Infection with HIV or active Hepatitis B or C, unless discussed and approved by Investigator and Sponsor
- Score of 10 or higher on PHQ-8 depression scale or any positive response on Columbia-Suicide Severity Rating Scale
- Uncontrolled medical or psychiatric conditions that could affect study data interpretation or require hospitalization within the last 6 months
- Use of afamelanotide or dersimelagon within 2 months before starting the run-in period
- Total bilirubin level greater than twice the upper limit of normal unless Gilbert syndrome is documented
- Pregnancy or breastfeeding
- Participation in another clinical trial involving experimental therapy or devices within 30 days before screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Cleveland Clinics
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
C
Cristina Garrido
CONTACT
M
Mireia Pujals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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