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

NCT06415019 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2024-08-14

No results posted yet for this 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 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.

Conditions

  • Pain
  • Healthy Volunteers

Interventions

DRUG

Naproxen (BAYH006689)

BAYH006689 gel will be dispensed directly on the patch

DRUG

Placebo Gel

Placebo gel will be dispensed directly on the patch

DRUG

A solution of 0.9% Saline

0.9% Saline will be dispensed directly on the patch.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2024-08-01
Completion
2024-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06415019 on ClinicalTrials.gov