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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: Completed Phase 1 study, sponsored by Bayer.

NCT06415019 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 236 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (293% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Skin sensitization will be based on specific scoring criteria.

Interventions

  • DRUG Placebo Gel
  • DRUG Naproxen (BAYH006689)
  • DRUG A solution of 0.9% Saline

Trial Details

FieldValue
Enrollment Target 236 participants
Start Date 2024-06-05
Est. Completion 2024-08-01
Phase Phase 1
Bayer

591 total trials

What the finished NCT06415019 record still lists

NCT06415019 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (293% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo Gel is the first listed.

NCT06415019 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT06415019's enrollment target sits among peer trials

236 212th of 2000 higher than 1,789 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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Source: ClinicalTrials.gov NCT06415019, the US trial registry maintained by the National Library of Medicine. NCT06415019 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.