Clinical trial NCT06415019: A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Healthy Volunteers
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Skin sensitization potential
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research, Inc.
state: New Jersey
Study officials:
References: