Dermatitis, PhotoallergicPhase 3NCT04532164
Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants
A Phase 3 study testing Butenafine HCl 1% (BAY1896425) - Induction Phase and Butenafine HCl 1% (BAY1896425) - Challenge Phase in people with Dermatitis, Photoallergic, run by Bayer at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Photoallergic
- What is being tested?
- Butenafine HCl 1% (BAY1896425) - Induction Phase and Butenafine HCl 1% (BAY1896425) - Challenge Phase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2013to 11 Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HT201309- Human Photoallergy Test
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.
- Conditions
- Dermatitis, Photoallergic
- Being tested
- Butenafine HCl 1% (BAY1896425) - Induction Phase, Butenafine HCl 1% (BAY1896425) - Challenge Phase
- Medical subject headings
- Dermatitis, Photoallergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butenafine HCl 1% (BAY1896425) - Induction PhaseDrug
Also called Antifungal Cream V61-044 containing Trolamine
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.
Butenafine HCl 1% (BAY1896425) - Challenge PhaseDrug
Also called Antifungal Cream V61-044 containing Trolamine
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.
| Study group | Role | What they receive |
|---|---|---|
| Photoallergic reaction test | Experimental | 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. Receives: Drug: Butenafine HCl 1% (BAY1896425) - Induction Phase; Drug: Butenafine HCl 1% (BAY1896425) - Challenge Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 24, 48, and 72 hours following patch application
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.
Measured: At 24, 48, and 72 hours following patch application
Secondary outcomes (6)
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.
Measured: Two or three days after each irradiation during Induction Phase
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.
Measured: Two or three days after each irradiation during Induction Phase
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.
Measured: At 24, 48, and 72 hours following patch application
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.
Measured: Two or three days after each irradiation during Induction Phase
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.
Measured: Two or three days after each irradiation during Induction Phase
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.
Measured: At 24, 48, and 72 hours following patch application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start10 Jun 2013
- Primary completion11 Nov 2013
- Study completion11 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, PhotoallergicStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532164
- Sponsor's protocol ID
- 18155
- Status last verified
- Oct 2020
- First submitted
- 26 Aug 2020
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HT201309- Human Photoallergy Test
- ClinicalTrials.gov ID
- NCT04532164
- Acronym / sponsor ID
- 18155
- Conditions
- Dermatitis, Photoallergic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2013 (actual)
- Primary completion
- 11 Nov 2013 (actual)
- Study completion
- 11 Nov 2013 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Posted 16 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photoallergic reaction test | Experimental | Drug: Butenafine HCl 1% (BAY1896425) - Induction Phase, Drug: Butenafine HCl 1% (BAY1896425) - Challenge PhaseDuring 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Butenafine HCl 1% (BAY1896425) - Induction PhaseAlso: Antifungal Cream V61-044 containing TrolamineTo 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. | Drug | Photoallergic reaction test |
| Butenafine HCl 1% (BAY1896425) - Challenge PhaseAlso: Antifungal Cream V61-044 containing Trolamine5 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. | Drug | Photoallergic reaction test |
Primary outcome
Photoallergic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score During Challenge Phase - All Treated Subjects
Time frame: At 24, 48, and 72 hours following patch application
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
Time frame: At 24, 48, and 72 hours following patch application
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.
6 secondary outcomes
Development of Erythema on Treated Irradiated Test Sites During Induction Phase - All Treated Subjects
Time frame: Two or three days after each irradiation during Induction Phase
Development of Erythema on the Treated Non-irradiated Test Sites During Induction Phase - All Treated Subjects
Time frame: Two or three days after each irradiation during Induction Phase
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
Time frame: At 24, 48, and 72 hours following patch application
Development of Erythema on Treated Irradiated Test Sites During Induction Phase - All Evaluable Subjects
Time frame: Two or three days after each irradiation during Induction Phase
Development of Erythema on the Treated Non-irradiated Test Sites During Induction Phase - All Evaluable Subjects
Time frame: Two or three days after each irradiation during Induction Phase
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
Time frame: At 24, 48, and 72 hours following patch application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Butenafine HCl 1% (BAY1896425) - Induction Phase and Butenafine HCl 1% (BAY1896425) - Challenge Phase in people with Dermatitis, Photoallergic, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photoallergic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score During Challenge Phase - All Treated Subjects (time frame: At 24, 48, and 72 hours following patch application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.