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NCT06415019 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 236
- Enrollment target
NCT06415019 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 236 participants.
The verdict
NCT06415019, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 236 participants
- Enrollment target
Study 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
Interventions
- DRUG Placebo Gel
- DRUG Naproxen (BAYH006689)
- DRUG A solution of 0.9% Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2024-06-05 |
| Est. Completion | 2024-08-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06415019
The ClinicalTrials.gov registry entry for NCT06415019 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo Gel is the first listed.
NCT06415019 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06415019 about?
NCT06415019 is a clinical study titled "A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants". 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 ...
What is the current status of trial NCT06415019?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 236 participants. The study started on 2024-06-05. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT06415019?
The interventions under investigation include: Placebo Gel (DRUG), Naproxen (BAYH006689) (DRUG), A solution of 0.9% Saline (DRUG).
Who is sponsoring clinical trial NCT06415019?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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