Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause… (NCT04531527) | Clinical Trial Compass
CompletedPhase 3
Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause Irritant Reaction of the Skin to Ultra Violet Light in Healthy Human Subjects
United States32 participantsStarted 2013-06-24
Plain-language summary
In this study researchers want to gather information about the potential of Antifungal Cream V61-044 containing Trolamine to produce a phototoxic reaction on the skin. A phototoxic reaction is an irritant reaction of the skin to ultra violet light. In order to find this out the study drug will be applied to the skin of healthy human subjects. By using a solar simulator to generate a UV spectrum similar to that of sunlight the potential of the study drug to produce a superficial reddening of the skin will be measured.
Who can participate
Age range
18 Years – 60 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:
* Participants must have been between the ages of 18 and 60 years;
* Participants must have been lightly pigmented (Fitzpatrick skin phototypes I, II, III);
* Participants must have been in good general health as determined by the subject's medical history;
* Participants must have been willing to avoid tanning bed usage and additional sun exposure during the trial and follow-up period;
* Participants must have been willing to refrain from using any new topical products during the trial;
* Participants must have been able and willing to cooperate with the Investigator and research staff, to have test materials applied according to protocol, and to complete the full course of the trial;
* Participants must have been willing to report any medications taken during the trial and refrain from taking any medications during the trial that might produce photoreactions;
* If female, participants must produce a negative urine pregnancy test prior to the initiation and also at the completion of the trial.
Exclusion Criteria:
* Participants must not have had visible sunburn;
* Participants must not have had a history of sun hypersensitivity/photosensitivity, or photosensitive dermatoses;
* Participants must not have had a history of allergies or sensitivities to cosmetics, toiletries, or any dermatological products;
* Participants must not have recently used any systemic or topical drugs which could have caused a photoreaction or may have interfered with the trial;…
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
1
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score
Timeframe: Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation