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NCT06511973 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About Whether BAYH006689 Causes Skin Irritation When Applied as a Topical Gel in Healthy Participants
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT06511973 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 42 participants.
The verdict
NCT06511973, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study 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. 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 r
Interventions
- DRUG Placebo Gel
- DRUG Naproxen (BAYH006689)
- DRUG A solution of 0.9% Saline
- DRUG A solution of 0.2% SLS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2024-07-23 |
| Est. Completion | 2024-08-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06511973
The ClinicalTrials.gov registry entry for NCT06511973 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 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 4 interventions - of which Placebo Gel is the first listed.
NCT06511973 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06511973 about?
NCT06511973 is a clinical study titled "A Study to Learn About Whether BAYH006689 Causes Skin Irritation When Applied as a Topical Gel in Healthy Participants". 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...
What is the current status of trial NCT06511973?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2024-07-23. Estimated completion is 2024-08-20.
What interventions are being tested in trial NCT06511973?
The interventions under investigation include: Placebo Gel (DRUG), Naproxen (BAYH006689) (DRUG), A solution of 0.9% Saline (DRUG), A solution of 0.2% SLS (DRUG).
Who is sponsoring clinical trial NCT06511973?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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