PainPhase 1NCT06511973
A Study to Learn About Whether BAYH006689 Causes Skin Irritation When Applied as a Topical Gel in Healthy Participants
A Phase 1 study testing Naproxen (BAYH006689), A solution of 0.9% Saline and A solution of 0.2% SLS in people with Pain and Healthy Volunteers, run by Bayer at 1 site in United States.
Trial summary
Researchers are looking for a better way to treat muscle and joint pains. Researchers have seen that medicines which help reduce pain and inflammation could be safer when applied directly to the skin, called topical application, than when taken by mouth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Healthy Volunteers
- What is being tested?
- Naproxen (BAYH006689), A solution of 0.9% Saline and A solution of 0.2% SLS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 20 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult
- Is 18 years of age or older
- Free of any systemic or dermatological disorder that may interfere with results or increase risk of adverse events (AEs)
Who cannot join
- Has a condition and/or is using medications that may interfere with the study results
- Pregnant or planning to get pregnant or breastfeeding
- Is currently participating in any clinical testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of BAY H006689, Naproxen 10% Topical Gel in Healthy Subjects Using a Cumulative Irritant Patch Test Design
Researchers are looking for a better way to treat muscle and joint pains. Researchers have seen that medicines which help reduce pain and inflammation could be safer when applied directly to the skin, called topical application, than when taken by mouth. However, recent studies have found that using these medications on the skin can sometimes cause skin reactions such as redness, itching, or irritation in the area where the medication is applied.
BAYH006689 topical gel is under development for the treatment of muscle and joint pains.
Read more
In this study, participants will be healthy and will not benefit from BAYH006689. However, the study will provide information about how to test BAYH006689 in future studies with people who have muscle and joint pain.
The main purpose of this study is to check whether BAYH006689 topical gel causes any irritation to the skin in healthy participants using a patch test called cumulative irritant patch test design. To do this, researchers will apply gel to participants' skin once a day for 21 days. Skin reactions will be assessed using a scale which will provide a score for redness, swelling, and other signs of skin irritation.
In this study, researchers will randomly assign 4 sites adjacent to each other, on the back of the participants' bodies just below the shoulder blades.
The following treatment gels will be applied using a patch.
- BAYH006689
- Placebo, which looks like the study drug, but does not have any medicine in it.
- 0.2% sodium lauryl sulfate (is a common ingredient in personal care products and when in contact with skin it could cause some skin irritation)
- 0.9% saline
Each participant will be in this study for 22 days, which includes:
- a visit to the clinic within 21 days of the study start, to confirm if the participant can take part in the study.
- participants will receive their assigned treatment gels at the identified skin site for 21 days.
- an end of study visit on Day 22, during which the researchers will remove the designed patches and assess any signs of skin irritation.
During the study, the doctors and their study team will:
- do physical examinations
- check participants' health by performing urine tests
- ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
- Conditions
- Pain, Healthy Volunteers
- Being tested
- Naproxen (BAYH006689), Placebo Gel, A solution of 0.9% Saline, A solution of 0.2% SLS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen (BAYH006689)Drug
BAYH006689 gel will be dispensed directly on the patch
Placebo GelDrug
Placebo gel will be dispensed directly on the patch
A solution of 0.9% SalineDrug
0.9% Saline will be dispensed directly on the patch
A solution of 0.2% SLSDrug
0.2% SLS will be dispensed directly on the patch.
| Study group | Role | What they receive |
|---|---|---|
| BAYHO06689 | Experimental | Topical application of BAYH006689 naproxen 10% topical gel on the intact skin Receives: Drug: Naproxen (BAYH006689) |
| Placebo | Placebo comparator | Topical application of placebo gel which contains 0% of naproxen on the intact skin Receives: Drug: Placebo Gel |
| Negative control | Placebo comparator | Topical application of the sterile 0.9% saline (negative control) on the intact skin Receives: Drug: A solution of 0.9% Saline |
| Positive control | Active comparator | Topical application of the 0.2% sodium lauryl sulfate (SLS) (positive control) on the intact skin Receives: Drug: A solution of 0.2% SLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin sensitization potential measured by the mean and total cumulative irritancy score
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start23 Jul 2024
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511973
- Sponsor's protocol ID
- 22641
- Status last verified
- Sep 2024
- First submitted
- 11 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later 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.vivli.org 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 member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of BAY H006689, Naproxen 10% Topical Gel in Healthy Subjects Using a Cumulative Irritant Patch Test Design
- ClinicalTrials.gov ID
- NCT06511973
- Acronym / sponsor ID
- 22641
- Conditions
- Pain, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking for a better way to treat muscle and joint pains. Researchers have seen that medicines which help reduce pain and inflammation could be safer when applied directly to the skin, called topical application, than when taken by mouth. However, recent studies have found that using these medications on the skin can sometimes cause skin reactions such as redness, itching, or irritation in the area where the medication is applied.
BAYH006689 topical gel is under development for the treatment of muscle and joint pains.
In this study, participants will be healthy and will not benefit from BAYH006689. However, the study will provide information about how to test BAYH006689 in future studies with people who have muscle and joint pain.
The main purpose of this study is to check whether BAYH006689 topical gel causes any irritation to the skin in healthy participants using a patch test called cumulative irritant patch test design. To do this, researchers will apply gel to participants' skin once a day for 21 days. Skin reactions will be assessed using a scale which will provide a score for redness, swelling, and other signs of skin irritation.
In this study, researchers will randomly assign 4 sites adjacent to each other, on the back of the participants' bodies just below the shoulder blades.
The following treatment gels will be applied using a patch.
- BAYH006689
- Placebo, which looks like the study drug, but does not have any medicine in it.
- 0.2% sodium lauryl sulfate (is a common ingredient in personal care products and when in contact with skin it could cause some skin irritation)
- 0.9% saline
Each participant will be in this study for 22 days, which includes:
- a visit to the clinic within 21 days of the study start, to confirm if the participant can take part in the study.
- participants will receive their assigned treatment gels at the identified skin site for 21 days.
- an end of study visit on Day 22, during which the researchers will remove the designed patches and assess any signs of skin irritation.
During the study, the doctors and their study team will:
- do physical examinations
- check participants' health by performing urine tests
- ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BAYHO06689 | Experimental | Drug: Naproxen (BAYH006689)Topical application of BAYH006689 naproxen 10% topical gel on the intact skin |
| Placebo | Placebo comparator | Drug: Placebo GelTopical application of placebo gel which contains 0% of naproxen on the intact skin |
| Negative control | Placebo comparator | Drug: A solution of 0.9% SalineTopical application of the sterile 0.9% saline (negative control) on the intact skin |
| Positive control | Active comparator | Drug: A solution of 0.2% SLSTopical application of the 0.2% sodium lauryl sulfate (SLS) (positive control) on the intact skin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult
- Is 18 years of age or older
- Free of any systemic or dermatological disorder that may interfere with results or increase risk of adverse events (AEs)
Key exclusion criteria (3 listed)
- Has a condition and/or is using medications that may interfere with the study results
- Pregnant or planning to get pregnant or breastfeeding
- Is currently participating in any clinical testing
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 |
|---|---|---|
| Naproxen (BAYH006689)BAYH006689 gel will be dispensed directly on the patch | Drug | BAYHO06689 |
| Placebo GelPlacebo gel will be dispensed directly on the patch | Drug | Placebo |
| A solution of 0.9% Saline0.9% Saline will be dispensed directly on the patch | Drug | Negative control |
| A solution of 0.2% SLS0.2% SLS will be dispensed directly on the patch. | Drug | Positive control |
Primary outcome
Skin sensitization potential measured by the mean and total cumulative irritancy score
Time frame: 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later 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.vivli.org 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 member 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naproxen (BAYH006689), A solution of 0.9% Saline and A solution of 0.2% SLS in people with Pain and Healthy Volunteers, 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 3 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 19 Sep 2024. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Skin sensitization potential measured by the mean and total cumulative irritancy score (time frame: 22 days). 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 19 Sep 2024.