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

Pain Clinical Trial

Official title:

A Randomized, Controlled Study to Evaluate the Sensitizing Potential of BAY H006689, Naproxen 10% Topical Gel in Healthy Subjects Using a Repeat Insult Patch Test Design

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06415019
• Other study ID #: 22640
• Status: Recruiting
• Phase: Phase 1
• Start date: June 5, 2024
• Est. completion date: July 22, 2024

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 22, 2024
• Est. primary completion date: July 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Pain

Intervention

Drug:
• Naproxen (BAYH006689)
BAYH006689 gel will be dispensed directly on the patch
• Placebo Gel
Placebo gel will be dispensed directly on the patch
• A solution of 0.9% Saline
0.9% Saline will be dispensed directly on the patch.

Locations

Country	Name	City	State
United States	TKL Research, Inc.	Fair Lawn	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin sensitization potential	Skin sensitization will be based on specific scoring criteria.	Up to 12 weeks

External Links

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