Clinical trial NCT04532164: Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants
Official title: HT201309- Human Photoallergy Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis, Photoallergic
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Subjects must have been between the ages of 18 and 60 years;
* Subjects must have been lightly pigmented with skin phototypes I - III, determined by the following guidelines: I-Always burns easily; never tans (sensitive); II-Always burns easily; tans minimally (sensitive); III-Burns moderately; tans gradually (light-brown) (normal);
* Subjects must have been in general good health as determined by the subject's medical history;
* Subjects must have been willing to avoid tanning bed usage and additional sun exposure during the study and follow-up period;
* Subjects must have been willing to refrain from using any new topical products during the trial;
* Subjects 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;
* Subjects 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, produced a negative urine pregnancy test prior to the initiation and also at the completion of the study.

Exclusion Criteria:

* Subjects with a visible sunburn;
* Subjects who had a history of sun hypersensitivity, photosensitivity, or photosensitive dermatoses;
* Subjects with a history of allergies or sensitivities to cosmetics, toiletries, or any dermatological products;
* Subjects who had recently used any systemic or topical drugs which can cause a photoreaction or may interfere with the trial;
* Subjects with any known skin conditions that might have interfered with the proper conduct of the trial;
* Subjects with scars, moles, excessive hair, or other blemishes over the mid or lower back which might have interfered with the test or the grading of the test sites;
* Subjects who had significant history of internal disease that may have interfered with the evaluation of the test material as determined by the Investigator;
* Female subjects who were pregnant, planning pregnancy, or nursing a child during the study period;
* Subjects who had used a tanning bed or other artificial tanning lights within the past two months;
* Subjects who had participated in a patch test involving the back within four weeks prior to the start of the trial;
* Subjects who would concurrently participate in any other clinical or consumer test;
* Subjects who had other conditions considered by the Investigator as sound reasons for disqualification from enrollment into the trial.

Primary outcomes:
measure: Photoallergic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score During Challenge Phase - All Treated Subjects
timeFrame: At 24, 48, and 72 hours following patch application
measure: Photoallergic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score During Challenge Phase - All Evaluable Subjects
timeFrame: At 24, 48, and 72 hours following patch application
Secondary outcomes:
measure: Development of Erythema on Treated Irradiated Test Sites During Induction Phase - All Treated Subjects
timeFrame: Two or three days after each irradiation during Induction Phase
measure: Development of Erythema on the Treated Non-irradiated Test Sites During Induction Phase - All Treated Subjects
timeFrame: Two or three days after each irradiation during Induction Phase
measure: Development of Erythema on the Treated Non-irradiated Test Sites During Challenge Phase Reported as Number of Test Site With Different Erythema Score - All Treated Subjects
timeFrame: At 24, 48, and 72 hours following patch application
measure: Development of Erythema on Treated Irradiated Test Sites During Induction Phase - All Evaluable Subjects
timeFrame: Two or three days after each irradiation during Induction Phase
measure: Development of Erythema on the Treated Non-irradiated Test Sites During Induction Phase - All Evaluable Subjects
timeFrame: Two or three days after each irradiation during Induction Phase
measure: Development of Erythema on the Treated Non-irradiated Test Sites During Challenge Phase Reported as Number of Test Site With Different Erythema Score - All Evaluable Subjects
timeFrame: At 24, 48, and 72 hours following patch application
Other outcomes:
Locations:
city: Fairfield
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: