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Antifungal Agent

Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants

Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24, 48, and 72 hours following patch application
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

Allergic skin reaction can be produced by the combination of a chemical product applied to the skin and ultraviolet (UV) radiation (a type of invisible light that comes from the sun and other light sources and can hurt your skin and eyes) received by the person. The researchers in this study wanted to find out if cream V61-044 might cause an allergic skin reaction to sunlight when applied to the skin in healthy participants. Cream V61-044 (brand name: LOTRIMIN ULTRA) is an approved drug used to treat infections caused by fungi (small growing organisms such as mold, mildew, yeast or mushrooms). Participants joining this study underwent two study phases: in Induction phase, participants received the test cream and UV radiation twice a week for 3 weeks; after 10 days of rest, in Challenge phase participants received the test cream and UV radiation once again. In both phases, the test cream was applied to two test areas on the upper back of the participants and to one of the test area UV radiation was applied. Evaluation on the skin rash was conducted two days after each UV radiation.

Eligible Conditions
  • Photoallergy
  • Photoallergic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24, 48, and 72 hours following patch application
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24, 48, and 72 hours following patch application for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Erythema
Photoallergic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score During Challenge Phase - All Treated Subjects
Secondary study objectives
Development of Erythema on Treated Irradiated Test Sites During Induction Phase - All Evaluable Subjects
Development of Erythema on Treated Irradiated Test Sites During Induction Phase - All Treated Subjects
Erythema
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Photoallergic reaction testExperimental Treatment2 Interventions
During the Induction Phase, participants received Butenafine HCl 1% on the treated irradiated skin test site followed by UV irradiation and on the treated non-irradiated skin test site without UV radiation, two times per week for three consecutive weeks. After 10 days of Rest Phase, during the Challenge Phase, participants received same procedure on the two virgin sites (treated sites) as in Induction Phase, and two additional sites with no Butenafine HCl 1% (untreated sites) were also occluded. Test sites were evaluated at 24, 48, and 72 hours after irradiation using the same grading scale used during Induction Phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trolamine
FDA approved
Butenafine
FDA approved

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,277 Previous Clinical Trials
25,540,976 Total Patients Enrolled
1 Trials studying Photoallergy
56 Patients Enrolled for Photoallergy
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,733 Total Patients Enrolled
1 Trials studying Photoallergy
56 Patients Enrolled for Photoallergy
~11 spots leftby Dec 2025