A Study to Learn About Whether BAYH006689 Causes Skin Irritation When Applied as a Topical Gel in Healthy Participants

NCT ID: NCT06511973

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-23
• Study Completion Date: 2024-08-20

Brief 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 remove the designed patches and assess any signs of skin irritation.

During the study, the doctors and their study team will:

• do physical examinations
• 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 if they think it is related or not to the study treatment.

Conditions

Pain; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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

Positive control

Topical application of the 0.2% sodium lauryl sulfate (SLS) (positive control) on the intact skin

Group Type: ACTIVE_COMPARATOR

A solution of 0.2% SLS

Intervention Type: DRUG

0.2% SLS will be dispensed directly on the patch.

Interventions

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

A solution of 0.2% SLS

0.2% SLS will be dispensed directly on the patch.

Intervention Type: DRUG

Eligibility Criteria

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

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TKL Research, Inc.

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

22641

Identifier Type: -

Identifier Source: org_study_id