HypersensitivityPhase 3NCT04531540

Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)

A Phase 3 study testing Butenafine HCl 1% (BAY1896425) in people with Hypersensitivity, run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Hypersensitivity
What is being tested?: Butenafine HCl 1% (BAY1896425)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: 1 siteUnited States
Study dates: 9 Sep 2013to 18 Oct 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 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must have been aged 18 to 79 years, inclusive;
Female subjects must have produced a negative urine pregnancy test prior to the initiation and also at the completion of the trial;
Subjects must have been capable of understanding and following directions.

Who cannot join

Subjects who were in ill health or taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial;
Subjects who had any visible skin disease that might be confused with a skin reaction to the test material;
Subjects who were participating in another clinical trial at this facility or any other facility;
Subjects who used topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial;
Subjects who had a history of adverse reactions to adhesive tape, cosmetics, OTC drugs or other personal care products;
Subjects judged by the PI to be inappropriate for the trial;
Female subjects who were pregnant as evidenced by a urine pregnancy test, planning to become pregnant, or nursing during the course of the trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Fairfield, New Jersey, 07004

Other trials in United States

About this study

Official title: HT201321- Repeated Insult Patch Test With Modified Challenge

In this study researcher want to learn more about possible skin reactions such after repeated application of an antifungal cream containing Trolamine. They are especially interested in skin irritations or allergic skin reactions. The study plans to enroll about 225 female or male participants with the age 18 - 79 years. The antifungal test cream will be applied on the back between the shoulder blades of the participants and covered by a special dressing patch. This will be repeated 3 times a week for the first 3 weeks of this study applying the cream on the same area of the back. At each visit the skin will be investigated for redness, dryness and other reactions. After a rest period of two weeks the test cream will be applied on the same skin area as before and on a second new skin area nearby. After 2 and 4 days the two skin areas will again be investigated for redness, dryness and other reactions.

Conditions: Hypersensitivity
Being tested: Butenafine HCl 1% (BAY1896425)
Medical subject headings: Hypersensitivity

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 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.

Study groups in NCT04531540
Study group	Role	What they receive
Repeated Insult Patch Test	Experimental	During the Induction Phase, participants received 0.2 g Butenafine HCl 1% covered by an occlusive patch on the upper back skin test site three times a week for a total of 9 applications. Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system. After 14 days of Rest Phase, on the first day of Challenge Phase, participants received same procedure on original Induction Phase test site and on a virgin test site. The patches were removed and the sites scored 48 hours after application and scored again at 96 hours after application. The test sites were evaluated using the Induction Phase scoring system. Receives: Drug: Butenafine HCl 1% (BAY1896425)

What is being measured

The primary outcome is the main question the study is designed to answer.

Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Measured: After 4 weeks
Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Measured: After 6 weeks
Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Measured: After 4 weeks
Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Measured: After 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 201318 Oct 2013

First posted28 Aug 2020
Study start9 Sep 2013
Primary completion18 Oct 2013
Study completion18 Oct 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 HypersensitivityStudies 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: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04531540
Sponsor's protocol ID: 18156
Status last verified: Oct 2020
First submitted: 26 Aug 2020
Last updated: 17 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
Recruiting
BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma
Asthma
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Not yet recruitingPhase 2
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
Epinephrine, Hypersensitivity, Immediate
Active, not recruitingPhase 2
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
SSM, Mastocytosis, Indolent

All Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HT201321- Repeated Insult Patch Test With Modified Challenge
ClinicalTrials.gov ID: NCT04531540
Acronym / sponsor ID: 18156
Conditions: Hypersensitivity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 9 Sep 2013 (actual)
Primary completion: 18 Oct 2013 (actual)
Study completion: 18 Oct 2013 (actual)
First posted: 28 Aug 2020 (actual)
Results: Posted 25 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Repeated Insult Patch Test	Experimental	Drug: Butenafine HCl 1% (BAY1896425)During the Induction Phase, participants received 0.2 g Butenafine HCl 1% covered by an occlusive patch on the upper back skin test site three times a week for a total of 9 applications. Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system. After 14 days of Rest Phase, on the first day of Challenge Phase, participants received same procedure on original Induction Phase test site and on a virgin test site. The patches were removed and the sites scored 48 hours after application and scored again at 96 hours after application. The test sites were evaluated using the Induction Phase scoring system.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects must have been aged 18 to 79 years, inclusive;
Female subjects must have produced a negative urine pregnancy test prior to the initiation and also at the completion of the trial;
Subjects must have been capable of understanding and following directions.

Key exclusion criteria (7 listed)

Subjects who were in ill health or taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial;
Subjects who had any visible skin disease that might be confused with a skin reaction to the test material;
Subjects who were participating in another clinical trial at this facility or any other facility;
Subjects who used topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial;
Subjects who had a history of adverse reactions to adhesive tape, cosmetics, OTC drugs or other personal care products;

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 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.	Drug	Repeated Insult Patch Test

Primary outcome

Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects
Time frame: After 4 weeks
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects
Time frame: After 6 weeks
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects
Time frame: After 4 weeks
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects
Time frame: After 6 weeks
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.

Results and safety

Results posted to the registry on 25 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Repeated Insult Patch Test	225	216

Primary outcome: Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects

Time frame: After 4 weeks. Number. Unit: Test site

Measure	Repeated Insult Patch Test n = 225
score=0	2182
score=0.5	2

Primary outcome: Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects

Time frame: After 6 weeks. Number. Unit: Test site

Measure	Repeated Insult Patch Test n = 225
score=0	1296
score=0.5	0

Primary outcome: Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects

Time frame: After 4 weeks. Number. Unit: Test site

Measure	Repeated Insult Patch Test n = 216
score=0	2158
score=0.5	2

Population analysed: Subjects who received treatment and completed the trial and had evaluable data

Primary outcome: Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects

Time frame: After 6 weeks. Number. Unit: Test site

Measure	Repeated Insult Patch Test n = 216
score=0	1296
score=0.5	0

Population analysed: Subjects who received treatment and completed the trial and had evaluable data

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Repeated Insult Patch Test	0 of 225 (0%)	6 of 225 (2.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 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.

Related trials for Hypersensitivity

Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
Recruiting
BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma
Asthma
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Not yet recruitingPhase 2
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
Epinephrine, Hypersensitivity, Immediate
Active, not recruitingPhase 2
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
SSM, Mastocytosis, Indolent

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 Hypersensitivity, 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 3 inclusion and 7 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 17 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 25 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?

Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects (time frame: After 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04531540.

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 17 Nov 2020; AzTrials last refreshed its copy on 26 Oct 2026.