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New gel could soothe stubborn back itch

NCT ID NCT06262607

Symptom relief Sponsor: Clexio Biosciences Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a gel called CLE-400 for chronic itching in adults with notalgia paresthetica, a nerve-related condition that causes persistent itch on the back. Fifty-nine participants applied the gel or a placebo daily for four weeks. Researchers measured how much the worst itch improved using a 0-to-10 scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CLE-400 topical gel
What this could lead to
If it works, this could point toward a new treatment for chronic itching in people with notalgia paresthetica.
What could go wrong
This is an early Phase 2 study with only 59 participants, so results may not apply to everyone. The gel may not reduce itch better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

59 people

The number who actually took part.

Started

Jan 2024

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject has a confirmed diagnosis of Notalgia Paresthetica. * Subject has a history of chronic pruritus (itch) due to Notalgia Paresthetica. * Subject has moderate to severe pruritus. * Subject is able and competent to read and sign the informed consent form (ICF). Exclusion Criteria: * Subject has chronic pruritus that is related to a condition other than Notalgia Paresthetica. * Subject with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease, including physical/laboratory/ECG/vital signs abnormality that would put the subject at undue risk or interfere with interpretation of study results * Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pruritus in adult subjects with notalgia paresthetica (NP)

Contacts and locations

Locations

  • Clinical Site 02

    Indianapolis, Indiana, 46250, United States

  • Clinical Site 06

    San Antonio, Texas, 78213, United States

  • Clinical Site 09

    Dublin, Ohio, 43016, United States

  • Clinical Site 10

    North Miami Beach, Florida, 33116, United States

  • Clinical Site 13

    Margate, Florida, 33063, United States

  • Clinical Site 15

    New York, New York, 10028, United States

  • Clinical Site 20

    Portsmouth, New Hampshire, 03801, United States

  • Clinical Site 21

    Fremont, California, 94538, United States

  • Clinical Site 23

    Methuen, Massachusetts, 01844, United States

  • Clinical site 01

    Coral Gables, Florida, 33134, United States

  • Clinical site 03

    High Point, North Carolina, 27262, United States

  • Clinical site 11

    Bryant, Arkansas, 72022, United States

  • Clinical site 16

    Houston, Texas, 77004, United States