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

A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of BAY H006689, Naproxen 10% Topical Gel in Healthy Subjects Using a Cumulative Irritant Patch Test Design

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Healthy Volunteers
• Intervention / Treatment: Drug: Naproxen (BAYH006689); Drug: Placebo Gel; Drug: A solution of 0.9% Saline; Drug: A solution of 0.2% SLS

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • Recruiting
      • TKL Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAYHO06689; Topical application of BAYH006689 naproxen 10% topical gel on the intact skin	Drug: Naproxen (BAYH006689); BAYH006689 gel will be dispensed directly on the patch
Placebo Comparator: Placebo; Topical application of placebo gel which contains 0% of naproxen on the intact skin	Drug: Placebo Gel; Placebo gel will be dispensed directly on the patch
Placebo Comparator: Negative control; Topical application of the sterile 0.9% saline (negative control) on the intact skin	Drug: A solution of 0.9% Saline; 0.9% Saline will be dispensed directly on the patch
Active Comparator: Positive control; Topical application of the 0.2% sodium lauryl sulfate (SLS) (positive control) on the intact skin	Drug: A solution of 0.2% SLS; 0.2% SLS will be dispensed directly on the patch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Skin sensitization potential measured by the mean and total cumulative irritancy score	22 days

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Estimated): August 19, 2024
• Study Completion (Estimated): August 19, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Pharmaceutical Solutions; Naproxen
• Other Study ID Numbers: 22641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No