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 range

18 Years – 45 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Minimal erythema dose

Timeframe: after 24 hours once weekly respectively, for 5 weeks in total

Trial details

NCT IDNCT06710600

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-09

View on ClinicalTrials.gov More Phototoxicity trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

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.

Phototoxicity of Frequently Prescribed Medicines

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Phototoxicity of Frequently Prescribed Medicines

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria