Topical CBD and urea lotion for itch relief in scleroderma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 3, controlled crossover trial at Khon Kaen University compares a 10% urea lotion with 1% CBD against a 10% urea lotion alone in adults with systemic sclerosis and chronic pruritus. Participants will apply assigned lotions during study periods and report itch severity, sleep disturbance, and skin hydration while investigators measure skin melanin and monitor for side effects. The protocol requires stability of immunosuppressive and steroid doses, and temporary washout of moisturizers and certain sleep medications before enrollment. The main goal is to see if adding 1% CBD provides meaningful itch relief and improves skin measures without significant adverse effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Khon Kaen University
  Khon Kaen, Thailand Recruiting

Study contacts

• Study coordinator: Chingching Foocharoen, MD
• Email: fching@kku.ac.th
• Phone: 6643363746

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.