Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma
Sponsored by Khon Kaen University
About this trial
Last updated 5 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started 5 months ago
What is this trial about?
What are the participation requirements?
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
