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

NCT06511973 | Completed Phase 1 FDA Drug

• 1 other identifier: 22641
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Skin sensitization potential measured by the mean and total cumulative irritancy score

  22 days

Study Arms (4)

BAYHO06689

EXPERIMENTAL

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

Drug: Naproxen (BAYH006689)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Gel

Negative control

PLACEBO COMPARATOR

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

Drug: A solution of 0.9% Saline

Positive control

ACTIVE COMPARATOR

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

Drug: A solution of 0.2% SLS

Interventions

Naproxen (BAYH006689) DRUG

BAYH006689 gel will be dispensed directly on the patch

BAYHO06689

Placebo Gel DRUG

Placebo gel will be dispensed directly on the patch

Placebo

A solution of 0.9% Saline DRUG

0.9% Saline will be dispensed directly on the patch

Negative control

A solution of 0.2% SLS DRUG

0.2% SLS will be dispensed directly on the patch.

Positive control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

TKL Research, Inc.

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Naproxen; Sodium Chloride; long-chain-aldehyde dehydrogenase

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 22, 2024
• Study Start: July 23, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)