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CBD lotion tested for scleroderma itch in new study

NCT ID NCT07245238

Symptom relief Sponsor: Khon Kaen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a lotion containing 1% hemp extract (CBD) plus 10% urea can relieve itching, improve skin moisture, and help sleep in people with scleroderma. About 36 adults with chronic itching will use both the CBD lotion and a plain urea lotion at different times to compare effects. The goal is to find a safe, effective option for a symptom that currently has no standard treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 70 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: 1. SSc patients aged between 18 and 70 years 2. Diagnosed according to ACR/EULAR 2013 classification criteria 3. Having chronic pruritus 4. Must not receive steroid equivalent to prednisolone dose more than 10 mg/d 5. Must receive a stable dose of steroid, immunosuppressant and/or vitamin or its supplement within 2 weeks before enrollment 6. Must stop moisturizer treatment at least 1 week prior to randomization 7. Must stop anxiolytics, hypnotics or sleeping pills at least 2 weeks before enrollment 8. Understand and able to read and write Thai language Exclusion Criteria: 1. Overlap with other connective tissue diseases 2. Pregnancy or lactation 3. Bedridden and confined to no self-care 4. Evidence of active malignant disease 5. Present of uncontrolled or severe medical problems including diabetes mellitus, asthma, angina, cardiovascular, thyroid, hepatobiliary included cholestasis, or renal diseases (Cr\>1.4 mg/dl) 6. Present of active infection that needs systemic antibiotic 7. Previous allergy to urea cream, cannabinoid or its derivatives 8. Concomitant illegal drug used (amphetamine or its derivative, cocaine) 9. On-going anxiolytics, hypnotics or sleeping pills used 10. In a period that needs immunosuppressant dose adjustment 11. Having history of schizophrenia, concurrent active mood disorder, or anxiety disorders 12. Having dermatologic diseases causing pruritus such as atopic dermatitis, contact dermatitis, psoriasis, folliculitis, urticaria, lichen planus, bullous pemphigoid, dermatophytosis, pediculosis, scabies, cutaneous T cell lymphoma, sunburn, drug allergy or skin eruption 13. Having systemic diseases causing of pruritus other than SSc such as neurologic disease, polycythemia vera

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Conditions

The condition(s) this trial relates to.

insomnia Pruritus systemic sclerosis

As listed by the trial registrant

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

Intervention study Mediciine Systemic sclerosis (SSC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Khon Kaen University

    RECRUITING

    Khon Kaen, 40002, Thailand

More trials for these conditions

Other studies related to the condition(s) this trial covers.