Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415019
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-05-10
Brief Title:
A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants
Sponsor:
Bayer
Organization:
Bayer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
09 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
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
09 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None