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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: Completed Phase 1 study, sponsored by Bayer.
NCT06511973 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT06511973 record still lists
NCT06511973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo Gel is the first listed.
NCT06511973 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06511973's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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