Study of Esflurbiprofen Hydrogel Patch Adhesion in Healthy Volunteers

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What is this study about?

A skin‑applied patch that contains the pain‑relieving medicine Esflurbiprofen is being tested. The patch is a thin, flexible transdermal patch that releases the drug through the skin. The study involves healthy adults who do not have a specific disease, and it focuses on how well the patch stays attached to the skin over time. “Topical” means the medication is applied to the surface of the skin rather than taken by mouth or injection, and “adhesion” refers to how firmly the patch sticks.

The purpose of the study is to assess the patch’s ability to remain adhered under normal daily conditions. Participants will have the patch placed on their skin and will be asked to look at it and report how it feels at a few set times, such as before bedtime and after waking. Study staff will also examine the patch at the same intervals and will remove it after a short period to record how well it stayed in place.

1 initial enrollment and orientation

after joining the study, receive written information about the study procedures and sign the consent form.

receive a single esflurbiprofen hydrogel patch that contains 165 mg of the active ingredient, with a total dose of 330 mg as indicated on the product label.

2 patch application

apply the patch to clean, dry, hair‑free skin on the designated area as instructed by the study staff.

ensure the patch adheres smoothly without wrinkles or air bubbles.

record the exact time of application in the study diary.

3 daily self‑assessment of adhesion

each evening, approximately one hour before bedtime, look at the patch and note how well it is sticking to the skin.

the next morning, approximately one hour after waking, repeat the visual check and note any changes.

enter these observations in the study diary, using the simple rating scale provided.

4 staff assessment before patch removal

five minutes before the scheduled removal time, a member of the study staff will examine the patch.

the staff member will mark the patch to record the level of adhesion at that moment.

this assessment is recorded as the primary endpoint of the study.

5 patch removal

remove the patch gently according to the instructions given by the staff.

place the used patch in the provided container for disposal.

record the removal time in the study diary.

6 final evaluation and study completion

return the study diary and any remaining materials to the study site.

participate in a brief final interview or questionnaire about the overall experience.

receive a summary of the study results if offered by the investigators.

Who Can Join the Study?

Be between 18 and 64 years old.
Be in a good state of health (feel generally well and have no major illnesses).
Be a non‑smoker or have stopped smoking for at least 3 months.
Sign a written informed consent after learning about the possible benefits, risks, and the insurance that protects participants.

Who Cannot Join the Study?

Any injury that could limit your ability to move your body.
Having very hairy skin where the patch would be placed.
Having a current skin problem or shaving the hair at the patch site.
Having a history of excessive sweating (hyperhidrosis) on the area where the patch would be applied.
Taking part in another clinical study within the past 30 days or at the same time.
Having drug or alcohol abuse, as judged by the study doctor.
Being pregnant or breastfeeding.
Being a woman who could become pregnant and not using a highly effective birth‑control method.
Being known to be allergic (hypersensitivity) to the study drug (Esflurbiprofen/R‑flurbiprofen) or any of its inactive ingredients (excipients).
Having existing heart (cardiac) or blood (haematological) diseases, or test results that might affect safety.
Having existing liver (hepatic) or kidney (renal) diseases, or test results that might affect safety.
Having known liver or kidney failure.
Having existing stomach or intestinal (gastrointestinal) diseases, or test results that might affect safety.
Having a history of serious brain (CNS) or mental health (psychiatric) disorders, or currently receiving treatment for them.
Having a systolic blood pressure lower than 90 mmHg or higher than 139 mmHg.
Having a diastolic blood pressure lower than 60 mmHg or higher than 89 mmHg.
Having a pulse (heart rate) lower than 50 beats per minute or higher than 90 beats per minute.
Using any medication that the study protocol lists as not allowed.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Dcn mwl Jmcfna Ujwuoq Scpaivk	Rheinbach	Germany
Psjko Dsb myce Hhpjfqollm Pknifrz Dndlkgwi Shnknfcqkqrdcvp Kqox	Brühl	Germany
Kkc Gwfvc	Gilching	Germany
Dit Hxbmel Pffwk	Fürstenfeldbruck	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.08.2023

Trial locations

Investigated Drugs:

Esflurbiprofen

Esflurbiprofen hydrogel patch is a small, flexible patch that is placed on the skin. It contains the medicine esflurbiprofen, which is an anti‑inflammatory drug that can help reduce pain. In this study the patch is applied to healthy volunteers to see how well it sticks to the skin over time. The researchers will check the patch’s adhesion (how firmly it stays attached) shortly before it is removed, to make sure it stays in place while delivering the medication through the skin.

Trial ID:

2023-503609-12-00

Protocol code:

TK-254RX-0106

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Esflurbiprofen Hydrogel Patch Adhesion in Healthy Volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?