Phototoxicity of Frequently Prescribed Medicines (NCT06710600) | Clinical Trial Compass
CompletedNot Applicable
Phototoxicity of Frequently Prescribed Medicines
Austria12 participantsStarted 2022-09-22
Plain-language summary
This pilot trial aims to study 10 selected commonly prescribed medicines with different grade of phototoxic potential. As there is no currently established way to assess phototoxic potential in a systematic and quantitative way, we want to test a novel radiation and measurement protocol to provide more granular information for patients and providers.
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent
✓. Male or female 18-45 years of age (limits included)
✓. BMI 19-27 for males and BMI 17-25 for females
✓. Vital parameters at screening within normal limits
✓. Electrocardiogram without clinically significant pathologic abnormalities and with QTc values lesser than 450 ms
✓. Skin type II-IV on Fitzpatrick scale (table 1)
✓. Women of childbearing potential agree to use adequate birth control methods during the entire study period. For all females, negative pregnancy test at screening and once monthly is required. Acceptable methods of contraception include: oral contraceptives, intrauterine device, female or male condoms with spermicide, diaphragm with spermicide, contraceptive medication patch, contraceptive medication implant, contraceptive medication injection, abstinence, or surgical sterilization more than 3 months before randomization.
Exclusion criteria
✕. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test
✕. Lack of willingness or capacity to co-operate and comply with the study procedures appropriately
✕. Failure to perform screening or baseline examinations
✕. Regular use of any medication (prescription or over the counter) for prevention or treatment of any medical condition in the previous 2 months except intake of contraceptives
What they're measuring
1
Minimal erythema dose
Timeframe: after 24 hours once weekly respectively, for 5 weeks in total
✕. Intake of any medication throughout the active phase of the study that would interfere with the study procedure as per investigator's judgement
✕. Use of dietary supplements in the previous 4 weeks, incl St. John's Wort
✕. Exposure to UV-radiation (including direct or indirect sun exposure, solarium, phototherapy) or use of oral sun-protective substances and self-tanning products 2 weeks prior to first medication administration and during the entire study duration
✕. Scars, previous trauma, tattoos or any other condition on the inner side of the arms that would impede the study procedures