Dermatitis, PhototoxicPhase 3NCT04531527
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
A Phase 3 study testing Butenafine HCl 1% (BAY1896425) in people with Dermatitis, Phototoxic, run by Bayer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Phototoxic
- What is being tested?
- Butenafine HCl 1% (BAY1896425)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2013to 28 Jun 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
- 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.
Who cannot join
- 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;
- Participants must not have had any known skin conditions that might interfere with the proper conduct of the trial;
- Participants must not have had 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;
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- Participants must not have had significant history of internal disease that may have interfered with the evaluation of the test material as determined by the Investigator;
- Participants must not have been pregnant, planning pregnancy, or nursing a child during the trial period;
- Participants must not have used a tanning bed or other artificial tanning lights within the past two months;
- Participants must not have participated in a patch test involving the back within four weeks prior to the start of the trial;
- Participants must not have concurrently participated in any other clinical or consumer test;
- Participants must not have 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: HT201308- Human Phototoxicity Test
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.
- Conditions
- Dermatitis, Phototoxic
- Being tested
- Butenafine HCl 1% (BAY1896425)
- Medical subject headings
- Dermatitis, Phototoxic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butenafine HCl 1% (BAY1896425)Drug
Also called Antifungal Cream V61-044 containing Trolamine
Approximately 60 μl of Butenafine HCl 1% applied twice to the treated irradiated site and to the treated non-irradiated site for a total application of 240 μl of Butenafine HCl 1%.
| Study group | Role | What they receive |
|---|---|---|
| Phototoxicity reaction test | Experimental | Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by Ultraviolet Radiation (UV) irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation. Receives: Drug: Butenafine HCl 1% (BAY1896425) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score
Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; 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 plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants *3 time points = 87 sites).
Measured: Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation
Secondary outcomes (1)
Development of Erythema on the Treated Non-irradiated Test Sites, Which Would Indicate Irritant Contact Dermatitis and a Pre-existing Allergic Contact Dermatitis
Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; 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 plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants *3 time points = 87 sites).
Measured: Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start24 Jun 2013
- Primary completion28 Jun 2013
- Study completion28 Jun 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, PhototoxicStudies 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
- 32 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
- NCT04531527
- Sponsor's protocol ID
- 18154
- Status last verified
- Oct 2020
- First submitted
- 26 Aug 2020
- Last updated
- 13 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HT201308- Human Phototoxicity Test
- ClinicalTrials.gov ID
- NCT04531527
- Acronym / sponsor ID
- 18154
- Conditions
- Dermatitis, Phototoxic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2013 (actual)
- Primary completion
- 28 Jun 2013 (actual)
- Study completion
- 28 Jun 2013 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Posted 21 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phototoxicity reaction test | Experimental | Drug: Butenafine HCl 1% (BAY1896425)Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by Ultraviolet Radiation (UV) irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
- Participants must not have had any known skin conditions that might interfere 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)Also: Antifungal Cream V61-044 containing TrolamineApproximately 60 μl of Butenafine HCl 1% applied twice to the treated irradiated site and to the treated non-irradiated site for a total application of 240 μl of Butenafine HCl 1%. | Drug | Phototoxicity reaction test |
Primary outcome
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score
Time frame: Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation
Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; 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 plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants *3 time points = 87 sites).
1 secondary outcome
Development of Erythema on the Treated Non-irradiated Test Sites, Which Would Indicate Irritant Contact Dermatitis and a Pre-existing Allergic Contact Dermatitis
Time frame: Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
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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) in people with Dermatitis, Phototoxic, 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 13 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 21 Sep 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?
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score (time frame: Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation). 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 13 Nov 2020.