A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants
NCT06415019
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Bayer
Start date
2024-06-05
Number of sites
- Summary
- Researchers are looking for a better way to treat muscle and joint pain. 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 medicines on the skin can sometimes cause skin reactions such as redness, itching, or irritation in the area where the medicine is applied. However, reports of more serious side effects, affecting the entire body, from using these topical medicines are uncommon. The study treatment BAYH006689 is under development to treat muscle and joint pain. In this study, participants will be healthy and will not benefit from BAYH006689. However, the study will provide information on how to test BAYH006689 in future studies in people with muscle and joint pain. The main purpose of this study is to check if BAYH006689 topical gel causes any skin reactions in healthy participants. The skin reactions will be assessed using a scale. This scale will provide scores for redness, swelling, and other signs of skin irritation. In this study, researchers will randomly assign 3 sites, adjacent to each other, on the back of participants' bodies just below the shoulder blades. The following gels will be applied 10 times at these sites as a patch three times a week for 21 days and once after 14-17 days: * BAYH006689 * Placebo, which looks like the study drug but does not have any medicine in it. * 0.9 % saline Each participant will be in the study for around 6 to 8 weeks. During this time they will: * receive assigned treatment gels at the identified skin sites * have their skin reaction symptoms assessed During the study, the doctors and their study team will: * check the medical history of the participants * 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 of whether they think they are related or not to the study treatment.
- Short title
- A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants
- Official title
- A Randomized, Controlled Study to Evaluate the Sensitizing Potential of BAY H006689, Naproxen 10% Topical Gel in Healthy Subjects Using a Repeat Insult Patch Test Design
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-08-01
- First posted
- 2024-05-16
- Registry last updated
- 2024-08-14
- Primary completion date
- 2024-08-01
- Start date
- 2024-06-05
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Bayer
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06415019
- ClinicalTrials.gov ID
- NCT06415019
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Other
- Masking
- Triple masking
- Masking description
- The treatments (IPs and control) will not be blinded to investigative personnel involved in the preparation/application and removal of treatments. However, the Investigator and trained evaluator involved in the evaluation of responses, will remain blinded during the course of the study until Database Lock and finalization of the Statistical Analysis Plan.
- Masked roles
- Participants, Investigators, Outcome assessors
Sources for study design
Skin sensitization potential
Timeframe: Up to 12 weeks
Skin sensitization will be based on specific scoring criteria.
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- 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)
- 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
Sources for eligibility
- TKL Research, Inc.Fair Lawn, United States
Sources for sites