A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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BAYHO06689

Topical application of BAYH006689 naproxen 10% topical gel on the intact skin

Group Type EXPERIMENTAL

Naproxen (BAYH006689)

Intervention Type DRUG

BAYH006689 gel will be dispensed directly on the patch

Placebo

Topical application of placebo gel which contains 0% of naproxen on the intact skin

Group Type PLACEBO_COMPARATOR

Placebo Gel

Intervention Type DRUG

Placebo gel will be dispensed directly on the patch

Negative control

Topical application of the sterile 0.9% saline (negative control) on the intact skin

Group Type PLACEBO_COMPARATOR

A solution of 0.9% Saline

Intervention Type DRUG

0.9% Saline will be dispensed directly on the patch.

Interventions

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Naproxen (BAYH006689)

BAYH006689 gel will be dispensed directly on the patch

Intervention Type DRUG

Placebo Gel

Placebo gel will be dispensed directly on the patch

Intervention Type DRUG

A solution of 0.9% Saline

0.9% Saline will be dispensed directly on the patch.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes