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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.
Each participant will be in this study for 22 days, which includes:
During the study, the doctors and their study team will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAYHO06689 | Experimental | Topical application of BAYH006689 naproxen 10% topical gel on the intact skin |
|
| Placebo | Placebo Comparator | Topical application of placebo gel which contains 0% of naproxen on the intact skin |
|
| Negative control | Placebo Comparator | Topical application of the sterile 0.9% saline (negative control) on the intact skin |
|
| Positive control | Active Comparator | Topical application of the 0.2% sodium lauryl sulfate (SLS) (positive control) on the intact skin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen (BAYH006689) | Drug | BAYH006689 gel will be dispensed directly on the patch |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Skin sensitization potential measured by the mean and total cumulative irritancy score | 22 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research, Inc. | Fair Lawn | New Jersey | 07410 | United States |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
| Placebo Gel |
| Drug |
Placebo gel will be dispensed directly on the patch |
|
| A solution of 0.9% Saline | Drug | 0.9% Saline will be dispensed directly on the patch |
|
| A solution of 0.2% SLS | Drug | 0.2% SLS will be dispensed directly on the patch. |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| D012965 | Sodium Chloride |
| C038828 | long-chain-aldehyde dehydrogenase |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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