Topical CBD and urea lotion for itch relief in scleroderma
Efficacy of Topical Cannabidiol Lotion for Pruritus Relief, Hydrating, Sleep Quality, Quality of Life Improvement in Systemic Sclerosis: a Randomized Double Blinded Controlled Crossover Trial
This trial will test whether a 10% urea lotion containing 1% cannabidiol (CBD) reduces itching in adults with systemic sclerosis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Khon Kaen University Academic / other |
| Locations | 1 site (Khon Kaen) |
| Trial ID | NCT07245238 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–70 years old with systemic sclerosis (ACR/EULAR 2013) who have chronic pruritus, are on stable medications, can comply with required washouts, and can attend visits in Khon Kaen, Thailand.
Not a fit: Patients with overlap connective tissue diseases, active malignancy, uncontrolled severe medical conditions, pregnancy or breastfeeding, or inability to comply with protocol washouts or visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, the CBD-containing lotion could reduce itching, improve skin hydration, and lessen sleep disruptions caused by pruritus.
How similar studies have performed: Small prior reports showed 1% hemp extract creams relieved itching in eczema and helped heal fingertip ulcers in scleroderma, but topical CBD for SSc-related pruritus has not been proven in definitive controlled trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Khon Kaen
- Khon Kaen University — Khon Kaen, Thailand (Recruiting)
Study contacts
- Study coordinator: Chingching Foocharoen, MD
- Email: fching@kku.ac.th
- Phone: 6643363746
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.