Back to resultsStudy to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants
Primary Purpose
Dermatitis, Photoallergic
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Butenafine HCl 1% (BAY1896425) - Induction Phase
Butenafine HCl 1% (BAY1896425) - Challenge Phase
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Photoallergic
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Photoallergic reaction test
Arm Description
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.
Outcomes
Primary Outcome Measures
Photoallergic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score During Challenge Phase - All Treated Subjects
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all treated subjects.
Photoallergic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score During Challenge Phase - All Evaluable Subjects
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all evaluable subjects.
Secondary Outcome Measures
Development of Erythema on Treated Irradiated Test Sites During Induction Phase - All Treated Subjects
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The number of test sites with available scores from all 6 induction patches were reported for all treated subjects.
Development of Erythema on the Treated Non-irradiated Test Sites During Induction Phase - All Treated Subjects
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The mean score of test sites with available scores from all 6 induction patches were reported for all treated subjects.
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
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all treated subjects.
Development of Erythema on Treated Irradiated Test Sites During Induction Phase - All Evaluable Subjects
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The number of test sites with available scores from all 6 induction patches were reported for all evaluable subjects.
Development of Erythema on the Treated Non-irradiated Test Sites During Induction Phase - All Evaluable Subjects
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The mean score of test sites with available scores from all 6 induction patches were reported for all evaluable subjects.
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
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all evaluable subjects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04532164
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2013 (Actual)
Primary Completion Date
November 11, 2013 (Actual)
Study Completion Date
November 11, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Photoallergic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Photoallergic reaction test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Butenafine HCl 1% (BAY1896425) - Induction Phase
Other Intervention Name(s)
Antifungal Cream V61-044 containing Trolamine
Intervention Description
To each of two test sites, approximately 20 μl/cm^2 of the Butenafine HCl 1% was applied directly to the skin and covered with a 25 mm Hilltop chamber with a Webril pad (2 cm in diameter, within an area of approximately 3 cm^2), and tape was applied over the chamber to secure the occlusive patch to the skin. On the next day, the chambers were removed and both test sites were lightly wiped. Approximately 2 μl/cm^2 of Butenafine HCl 1% was reapplied directly to the skin and lightly spread over the treated irradiated test site. The treated non-irradiated test site did not receive a similar reapplication. Between 5 and 15 minutes after application, the treated irradiated test site was irradiated with two times the subject's Minimal Erythema Dose (MED). Evaluation of the test sites occurred two days after the irradiation. This procedure was repeated two times per week for three consecutive weeks for a total of 6 induction exposures per test site.
Intervention Type
Drug
Intervention Name(s)
Butenafine HCl 1% (BAY1896425) - Challenge Phase
Other Intervention Name(s)
Antifungal Cream V61-044 containing Trolamine
Intervention Description
5 μl/cm^2 of the Butenafine HCl 1% was applied directly to each of the two virgin sites (treated sites) adjacent to the induction patch sites and covered with Hilltop chambers with Webril pad and tape was applied over the chambers to secure the occlusive patches to the skin. Two additional sites with no Butenafine HCl 1% (untreated sites) were also occluded. Sites were at least 2.5 cm apart. The patches were removed 24 hours later and the sites were lightly wiped. Test sites were evaluated. Butenafine HCl 1% (2 μl/cm^2) was applied to the treated irradiated site. After 15 minutes, the treated irradiated site and the untreated irradiated site were irradiated with 0.5 MED of UVA/UVB irradiation followed by 10 Joules/cm^2 of UVA from a xenon arc solar simulator equipped with a Schott WG345 to eliminate UVB radiation. The remaining sites served as the treated non-irradiated site and untreated non-irradiated site.
Primary Outcome Measure Information:
Title
Photoallergic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score During Challenge Phase - All Treated Subjects
Description
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all treated subjects.
Time Frame
At 24, 48, and 72 hours following patch application
Title
Photoallergic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score During Challenge Phase - All Evaluable Subjects
Description
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all evaluable subjects.
Time Frame
At 24, 48, and 72 hours following patch application
Secondary Outcome Measure Information:
Title
Development of Erythema on Treated Irradiated Test Sites During Induction Phase - All Treated Subjects
Description
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The number of test sites with available scores from all 6 induction patches were reported for all treated subjects.
Time Frame
Two or three days after each irradiation during Induction Phase
Title
Development of Erythema on the Treated Non-irradiated Test Sites During Induction Phase - All Treated Subjects
Description
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The mean score of test sites with available scores from all 6 induction patches were reported for all treated subjects.
Time Frame
Two or three days after each irradiation during Induction Phase
Title
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
Description
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all treated subjects.
Time Frame
At 24, 48, and 72 hours following patch application
Title
Development of Erythema on Treated Irradiated Test Sites During Induction Phase - All Evaluable Subjects
Description
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The number of test sites with available scores from all 6 induction patches were reported for all evaluable subjects.
Time Frame
Two or three days after each irradiation during Induction Phase
Title
Development of Erythema on the Treated Non-irradiated Test Sites During Induction Phase - All Evaluable Subjects
Description
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The mean score of test sites with available scores from all 6 induction patches were reported for all evaluable subjects.
Time Frame
Two or three days after each irradiation during Induction Phase
Title
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
Description
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); score 1= faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=moderate to intense redness with well defined margins; score 3=redness with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all evaluable subjects.
Time Frame
At 24, 48, and 72 hours following patch application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Fairfield
State/Province
New Jersey
ZIP/Postal Code
07004
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Links:
URL
https://clinicaltrials.bayer.com/
Description
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Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants
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