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Efficacy and Safety of OXT-328 5% Topical Gel for Symptom Relief in Patients with Chemotherapy‑Induced, Diabetic, and Cervical Radiculopathy Peripheral Neuropathy

InvestigationalNo placebo
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What is this trial about?

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

The study involves people who have nerve pain caused by three different conditions: Chemotherapy-Induced Peripheral Neuropathy, which is nerve damage that can happen after cancer drugs; Diabetic Peripheral Neuropathy, which is nerve damage that can develop in people with diabetes; and Cervical Radiculopathy, which is a pinched nerve in the neck that can cause pain, tingling, or weakness in the arm. The treatment being tested is a 5% topical gel that contains the experimental medicine OXT-328. The gel is applied directly to the skin over the painful area.

The purpose of the study is to find out whether a single or short series of applications of this gel can quickly reduce pain and other symptoms in these conditions while being safe to use.

Participants will attend an initial clinic visit where the gel is applied for the first time, and they will be asked to continue applying the gel at home for up to ten days. They will keep a simple diary of how strong the pain feels and any feelings of discomfort at the application site. At the end of the treatment period, they will have a final check to report any changes in their symptoms and any side effects they experienced.

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 Assessment

    After you join the study, you will complete a baseline visit before any medication is given. During this visit you will rate your current pain using the GS‑NRS (a 0‑10 scale), answer questionnaires about your condition, and allow the study staff to record basic health information.

  2. Step 2

    First Application of Gel

    On Day 1 you will receive the study medication, OXT‑328 5% topical gel. A measured amount containing 800 mg of the active substance will be applied to the affected skin area in the clinic.

    You will remain in the clinic for two hours after the application. During this time the staff will ask you to rate your pain again with the GS‑NRS to assess the immediate effect of the first dose.

  3. Step 3

    Daily Home Applications – Days 2 and 3

    You will apply the same amount of OXT‑328 gel once each day at home on Day 2 and Day 3. Each application should be made to the same area as on Day 1.

    After each daily application you will record your pain score using the GS‑NRS. You will also complete a short questionnaire at the end of each day to report any sensations such as stinging, burning, itching, or redness at the application site.

  4. Step 4

    End‑of‑Day 3 Evaluation

    At the close of Day 3 you will answer the Patient Global Impression of Change (PGIC) question, indicating whether you feel “very much improved,” “much improved,” or another level of change.

    You will also complete disease‑specific questionnaires: the Brief Pain Inventory – Short Form (BPI‑SF) for pain severity and interference, the Neuropathy Total Symptom Score‑6 (NTSS‑6) if you have diabetic neuropathy, the Neck Disability Index (NDI) for cervical radiculopathy, and the Patient Specific Functional Scale (PSFS) as appropriate.

  5. Step 5

    Continued Daily Applications – Days 4 to 10

    You will continue to apply the OXT‑328 gel once daily from Day 4 through Day 10, using the same amount and technique as before.

    Each day you will record your GS‑NRS pain score and note any side effects, including local skin reactions or other discomforts.

  6. Step 6

    Final Application and Assessment

    On Day 10 you will apply the gel for the last time in the clinic. Two hours after this application you will rate your pain again with the GS‑NRS to evaluate the effect after the full treatment period.

  7. Step 7

    Safety Follow‑Up

    Throughout the trial you will be asked to report any treatment‑emergent adverse events (TEAEs) and any serious adverse events (SAEs). The study staff will assess the severity of any skin reactions such as stinging, burning, redness, maceration, itch, or dermatitis.

    If a serious side effect occurs, you may be asked to stop using the gel and receive appropriate medical care.

Who can join the trial?

14 criteria

  • Be an adult (18 years or older) who can give written informed consent – a signed agreement that you understand the study and agree to take part.
  • Be able to understand and speak Greek and follow all study tasks, such as completing an electronic diary, attending scheduled visits, and receiving the study treatment.
  • Be medically stable, without any sudden illness that could interfere with the study or its measurements.
  • If you are a woman, you must follow the study’s pregnancy testing and birth‑control rules.
  • If you are a man, you must follow the study’s birth‑control and sperm‑donation requirements.
  • For the chemotherapy‑induced nerve damage group (CIPN): have a doctor‑confirmed diagnosis of nerve pain caused by the chemotherapy drugs oxaliplatin or weekly paclitaxel.
  • For the CIPN group: have moderate‑to‑severe nerve pain rated 5–9 on a GS‑NRS scale (a 0‑10 rating where higher numbers mean worse pain), with a consistent pattern confirmed during the initial symptom‑mapping visit.
  • For the CIPN group: have a stable chemotherapy schedule that will allow you to stay in the study for its whole duration.
  • For the diabetes‑related nerve damage group (DPN): have type 2 diabetes for at least one year and be on a stable diabetes medication plan.
  • For the DPN group: have moderate‑to‑severe tingling, burning, or numbness in the feet (rated 5–9 on the GS‑NRS) that fits the pattern of early “small‑fiber” diabetic nerve damage.
  • For the DPN group: show clinical signs of early small‑fiber nerve problems while the larger nerve fibers (which control strength and reflexes) are still working normally.
  • For the neck‑nerve root pain group (CR): have a doctor’s diagnosis of one‑sided cervical radiculopathy, which means nerve irritation in the neck causing sensory symptoms (like tingling or numbness) in a specific skin area called a dermatomal distribution (C5‑T1 nerves).
  • For the CR group: have early or intermittent neck‑nerve symptoms that are moderate‑to‑severe (GS‑NRS 5–9).
  • For the CR group: be on a stable medication regimen (no frequent changes) and be able to follow the study’s symptom‑mapping and treatment procedures.

Who cannot join the trial?

22 criteria

  • Inability to give informed consent (meaning you cannot understand or agree to the study procedures) or follow the study steps.
  • Having taken a mix of chemotherapy drugs that can damage nerves (neurotoxic chemotherapy) and already having long‑term nerve damage that keeps getting worse.
  • Having an unusual pattern of nerve problems that does not match the typical symptoms the study is looking for.
  • Not being able to show a repeatable short‑term symptom pattern when nerves are affected.
  • Having other reasons for nerve problems besides diabetes, such as injuries or other medical conditions.
  • Having moderate to severe damage to the large nerve fibers (large‑fibre neuropathy), which are the main nerves that carry touch and movement signals.
  • Having diabetes that is not well‑controlled or is changing quickly (unstable diabetes).
  • Having foot problems (such as ulcers or infections) that could interfere with the skin treatment or the way the study measures outcomes.
  • Having nerve symptoms on both sides of the body or in areas that do not follow the normal skin pattern (non‑dermatomal symptoms).
  • Having compression of the spinal cord in the neck area (cervical myelopathy), which can cause serious problems.
  • Having significant weakness or loss of movement (motor deficits) in the neck or arms.
  • Having another diagnosis that could explain the neck or nerve symptoms.
  • Having had neck surgery at the same level where the study would apply the treatment.
  • Having recent neck procedures (such as injections or surgeries) that could affect the study results.
  • Using medicines or therapies that are not allowed in the study because they could change how nerve symptoms are measured.
  • Having serious kidney, liver, heart, infection, brain, mental health, or other medical problems that could make participation unsafe or affect study results.
  • Being allergic to the study drug (OXT‑328), the anti‑inflammatory ingredient sulindac, any of the inactive ingredients (excipients), the adhesive dressing (Tegaderm), or other medical adhesives.
  • Having skin conditions or structural problems at the area where the treatment would be applied, which could interfere with the medication or its assessment.
  • Being pregnant or breastfeeding.
  • Having taken part in another experimental drug study recently or currently using an experimental medication (investigational medicinal product).
  • Testing positive on a urine drug screen for substances that are not allowed in the study.
  • Any other condition that the study doctor thinks could interfere with safety, following the study plan, or interpreting the study results.
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Investigated drugs

OXT-328 is an experimental gel that is applied to the skin. In this study it is being tested to see if it can quickly reduce pain, tingling, and other uncomfortable feelings caused by nerve problems that come from chemotherapy, diabetes, or a neck condition called cervical radiculopathy. The gel is placed on the affected area, and researchers are looking to find out how fast it can bring relief after the first time it is used in the clinic.

What is already known about the treatment

OXT-328 - The medication is provided as a 5% topical gel that is rubbed onto the skin over the painful nerves. It is still an experimental drug being tested in a Phase 2a trial, so only early study results are available in the medical literature. The gel is being evaluated to ease symptoms of chemotherapy‑induced peripheral neuropathy, diabetic peripheral neuropathy, and cervical radiculopathy. It works by calming nerve‑cell signals and reducing local inflammation, and it is classified as a topical analgesic agent.

Investigated diseases

  • Chemotherapy‑induced peripheral neuropathy

    a condition where nerves in the arms and legs become damaged as a side effect of chemotherapy drugs. It typically starts with tingling or numbness in the fingertips and toes, and may spread upward. Over weeks to months, the sensations can become more intense and may include burning pain or loss of coordination. The symptoms often worsen during or after treatment cycles and can persist after therapy ends. It mainly affects sensory nerves but can also involve motor function.

  • Diabetic peripheral neuropathy

    nerve damage that occurs in people with long‑standing diabetes. It usually begins with numbness, tingling, or burning in the feet and may progress upward to the lower legs. As the condition advances, pain can increase and muscle weakness may develop, making walking difficult. Loss of sensation can lead to unnoticed injuries that heal slowly. The disease progresses gradually over years if blood‑sugar control remains poor.

  • Cervical radiculopathy

    irritation or compression of a nerve root in the neck region. It often starts with neck pain that radiates into the shoulder, arm, or hand. Numbness, tingling, or weakness may appear in the corresponding arm as the condition progresses. Symptoms can worsen with certain neck movements or prolonged positions. Over time, the nerve involvement can lead to reduced strength and coordination in the affected arm.

Trial detailsLast updated 17 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-527437-55-00Estimated enrolment45 patients

sourced from the EU Clinical Trials Register and site verification

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