Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511973
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
A Study to Learn About Whether BAYH006689 Causes Skin Irritation When Applied as a Topical Gel in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 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
02 sodium lauryl sulfate is a common ingredient in personal care products and when in contact with skin it could cause some skin irritation
09 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
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
02 sodium lauryl sulfate is a common ingredient in personal care products and when in contact with skin it could cause some skin irritation
09 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None