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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT06511973

Public ClinicalTrials.gov record NCT06511973. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 5:46 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT06511973
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Bayer
Industry
Enrollment
42 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 22, 2024
Primary completion
Aug 19, 2024
Completion
Aug 19, 2024
Last update posted
Sep 18, 2024

2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
TKL Research, Inc. Fair Lawn New Jersey 07410

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06511973, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 18, 2024 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06511973 live on ClinicalTrials.gov.

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