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โ† Trials
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Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma

RecruitingPhase 3Ages 18 Years - 70 YearsAllKhon Kaen University
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In plain words

What the trial is, and whether it could suit you

Itching is one of the common symptoms found in patients with scleroderma, with a prevalence of about 42-62%, and it often occurs in the early stages of the disease. The mechanisms of itching are still unclear, and current treatments have not yet shown any clear efficacy in alleviating itching caused by scleroderma. Hemp extract has previously been used to treat itching in chronic skin diseases. Besides its antipruritic (anti-itch) effect, hemp extract also possesses anti-inflammatory properties, increases skin moisture, and helps repair the skin, all without psychoactive effects. Studies have investigated the benefits of hemp extract in the form of a topical cream with concentrations ranging from 1-5% for the treatment of various skin diseases such as psoriasis, eczema, and the management of fingertip ulcers in scleroderma patients. The results showed that a 1% hemp extract cream reliev

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • 10% urea lotion plus 1% cannabidiol
  • Control
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Where

1 site
Khon Kaen University
Khon Kaen, Thailand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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