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Efficacy and safety of dexibuprofen (S‑ibuprofen) gel versus placebo for pain relief in patients with acute soft‑tissue contusions, with background paracetamol

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What is this trial about?

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

The study focuses on people who have suffered acute contusions of soft tissues as a result of blunt trauma, which are bruises that affect muscles, tendons, or skin without a cut. The treatment being tested is a skin‑applied gel containing (S)-ibuprofen gel at a 5 % concentration, which is a form of the common pain‑relieving medication ibuprofen. A matching gel without the active ingredient, called a placebo, is used for comparison.

The purpose of the study is to determine whether the ibuprofen gel provides better short‑term pain relief than the placebo for these types of bruises. Participants will receive a single application of the assigned gel once a day and will be asked to record their pain levels and any need for additional medication over the following week. Visits to the clinic will occur at the start, after 24 hours, and then several times during the first week to check pain, vital signs, and any side effects, while the overall safety and how well the gel is tolerated will also be monitored.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit (day 0)

    You arrive at the clinic and provide informed consent. the staff will ask questions about your health, perform a brief physical exam, and measure your vital signs.

    You will be randomly assigned to receive either s-ibuprofen gel 5% or a placebo gel. randomization means you will not know which gel you receive, and the assignment is made by a computer.

    You will receive a supply of the assigned gel, instructions on how to apply it, a pain diary to record your symptoms, and a supply of paracetamol 1000 mg tablets to use only if needed for rescue pain relief.

  2. Step 2

    First application of study gel

    Within a few hours after the baseline visit, apply 1.5 g of the gel to the injured area. the gel should be spread thinly over the skin and gently massaged in.

    Record the time of application and your pain level in the diary using the numeric rating scale (nrs), where 0 means no pain and 10 means the worst pain imaginable.

  3. Step 3

    Daily applications of study gel

    Each day for the next seven days, apply 1.5 g of the same gel once every 24 hours. use the same technique as the first application.

    Continue to record pain scores in the diary at the scheduled times (approximately every 2–4 hours during the first day and at later time points up to 168 hours). also note any side effects or skin reactions.

  4. Step 4

    Use of rescue medication

    If the pain becomes intolerable, you may take one tablet of paracetamol 1000 mg by mouth.

    Write the exact time you take the tablet and the dose in the diary. rescue medication should be used only when necessary and not exceed the amount advised by the study staff.

  5. Step 5

    Visit 2 – 24 hours after baseline

    Return to the clinic about 24 hours after the baseline visit.

    The investigator will ask you to rate pain on movement (pain on movement, pom) and pain at rest (pain at rest, par) using the nrs, measure vital signs, and review your diary for completeness.

    Tolerability of the gel will be assessed on a simple four‑point scale, and any adverse events will be recorded.

  6. Step 6

    Subsequent visits (days 2, 3, 4, and 7)

    You will attend follow‑up visits on approximately day 2, day 3, day 4, and day 7 (around 168 hours after the first application).

    At each visit the same assessments as at visit 2 will be performed: nrs pain scores, vital signs, tolerability rating, and documentation of any adverse events.

    The investigator will also ask about the time to first perceptible pain relief, time to meaningful relief, and any additional use of rescue medication.

  7. Step 7

    Final visit (day 7, end of study)

    The last clinic visit occurs about one week after the first gel application.

    All remaining study medication will be returned, the pain diary will be collected, and a final assessment of pain, tolerability, and safety will be completed.

    After this visit your participation in the trial is finished.

Who can join the trial?

7 criteria

  • Having an acute soft‑tissue injury (a recent bruise or damage to the muscles, tendons, or skin) called a contusion
  • Joining the study within 6 hours after the injury occurred
  • Reporting a pain level at the injured spot that is higher than 5 on an 11‑point numeric rating scale (NRS) where 0 means no pain and 10 means the worst pain possible
  • Having an injury size measured by the doctor that is at least 25 cm² and no more than 120 cm² (about the size of a small to medium postage stamp)
  • Being an adult, male or female, who is 18 years old or older
  • Signing a written informed consent form, which shows you understand the study and agree to take part
  • Being in overall good health as judged by the doctor after reviewing your medical history and doing a physical exam

Who cannot join the trial?

23 criteria

  • Having another serious injury at the same time, such as a bone break (fracture), damage to a nerve, torn ligament, torn muscle or cartilage, or an open wound.
  • Being able to become pregnant and not agreeing to use a reliable method of birth control during the study.
  • Having any allergy or strong reaction (like severe rash, hives, breathing problems, or swelling) to acetaminophen, ibuprofen, other pain‑relief medicines called NSAIDs, or any ingredient in the gel.
  • Having had a very serious skin reaction to any medicine, such as Stevens‑Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, or a widespread pustular rash.
  • Having any ongoing health problem that could change how the gel is absorbed, moved around, broken down, or removed by the body.
  • Having a major injury to the same arm or leg within the past 6 months.
  • Having a disease in the same area, such as joint inflammation (synovitis), rheumatoid arthritis, or osteoarthritis (wear‑and‑tear arthritis).
  • Showing signs of an infection in the injured area, including swelling of any nearby joint.
  • Having another painful condition in the area of the injury that is not the bruise being studied.
  • Having had surgery on the injured arm or leg within the past year.
  • Having serious illnesses that could put you at risk or affect the study results, such as a history of stomach bleeding, major heart disease, serious liver disease, or serious kidney disease.
  • Having very thick or hairy skin at the place where the gel would be applied that cannot be trimmed before use.
  • Having a blood‑clotting disorder that affects how blood normally clots.
  • Taking medicines that are not allowed in the study.
  • Having taken part in a previous study of this gel or living in the same household as someone who has.
  • Being closely related to anyone who is directly involved in running the study.
  • Having a current skin problem (such as rash, eczema, or infection) or shaving the area where the gel would be applied.
  • Having a history of excessive sweating (hyperhidrosis) on the area where the gel would be used.
  • Using any pain‑relief medicine that contains NSAIDs or other pain relievers within 36 hours before the study, opioids within 7 days, or steroids within 60 days.
  • Using long‑acting NSAIDs or any other topical medication on the injury since it occurred (the usual rest‑ice‑compression‑elevation care is allowed).
  • Having taken part in any other clinical study within 30 days before joining this study or while taking part in this study.
  • Having a positive test for drugs or alcohol, or a history of drug or alcohol abuse, as judged by the doctor.
  • Being pregnant, breastfeeding, or planning to become pregnant during the study period.
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Investigated drugs

  • Paracetamol

    is a common pain‑relieving medicine taken by mouth. In this study it is given to all participants as a background treatment to help manage any general pain they may have, but it is not the main focus of the trial.

  • (S)-Ibuprofen gel

    is a topical gel that contains the active ingredient dexibuprofen. It is applied directly to the skin over the injured area once a day. The gel is being tested to see if it can reduce pain and improve comfort in people with fresh soft‑tissue bruises caused by blunt trauma.

What is already known about the treatment

  • Paracetamol

    This medication is taken by mouth, usually as a tablet, and is one of the most common pain relievers and fever reducers used worldwide. It is an established drug that has been studied for many years and is available over the counter. It is mainly used for mild to moderate aches, headaches, and fever. It works by lowering the amount of pain‑causing chemicals in the brain and is classified as an analgesic and antipyretic.

  • Dexibuprofen

    The gel version of this drug is spread on the skin over the injured area and applied once every 24 hours. Dexibuprofen is a well‑known non‑steroidal anti‑inflammatory drug (NSAID) that is being tested in a topical form for bruises and soft‑tissue injuries. It is intended to relieve pain and reduce swelling in acute contusions. It works by blocking the enzymes that make prostaglandins, which cause inflammation and pain, and is classified as a topical NSAID.

Investigated diseases

Acute contusion of soft tissues - An acute contusion of soft tissues is a bruise that occurs when blunt force damages blood vessels within the muscle, fat, or skin. The injury causes localized bleeding, leading to pain, swelling, and discoloration at the site. In the first hours the area is tender and may feel warm. Over the next few days the swelling and color changes typically increase before beginning to subside. By one to two weeks the leaked blood is gradually reabsorbed, and the tissue returns to its normal appearance.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524451-31-00Protocol codeAP-009Estimated enrolment240 patients

sourced from the EU Clinical Trials Register and site verification

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