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Study of Esflurbiprofen Hydrogel Patch Adhesion in Healthy Volunteers

InvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

18 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Esflurbiprofen hydrogel patch 165 mg (EFHP) - This medication is applied to the skin as a transdermal patch that releases the drug through the skin surface. It is currently an investigational product and has not yet been approved for regular medical use, so information about it is limited in the scientific literature. The patch is being studied for possible use in relieving musculoskeletal pain, although this trial only looks at how well the patch sticks to the skin. Esflurbiprofen works by blocking enzymes called cyclo‑oxygenase, which lowers the production of chemicals that cause pain and swelling, and it belongs to the class of topical non‑steroidal anti‑inflammatory drugs (NSAIDs).

Investigated diseases

Conditions this trial is registered against

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503609-12-00Protocol codeTK-254RX-0106Estimated enrolment80 patientsSponsorTeikoku Seiyaku Co. Ltd.

sourced from the EU Clinical Trials Register and site verification

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