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

NCT06415019 | Completed Phase 1 FDA Drug

• 1 other identifier: 22640
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Skin sensitization potential

  Skin sensitization will be based on specific scoring criteria.

  Up to 12 weeks

Study Arms (3)

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

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

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

Related Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

MeSH Terms

Conditions

Pain

Interventions

Naproxen; Sodium Chloride

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: May 10, 2024
• First Posted: May 16, 2024
• Study Start: June 5, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)