RECRUITINGPhase 3INTERVENTIONAL

Topical Cannabidiol Lotion for Pruritus 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

About This Trial

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 relieved itching in eczema and at the same concentration also helped heal fingertip ulcers in scleroderma patients. However, to date, there has been no clear study on the effectiveness of hemp extract in cream or lotion form for treating itching in scleroderma patients. Additionally, there is currently no standard guideline for the management of itching in scleroderma. Generally, 10% urea cream is commonly used to increase skin moisture and alleviate itching, but there has been no prior study on its efficacy specifically for itch relief. Therefore, this study aims to evaluate the efficacy of a 1% hemp extract combined with 10% urea in lotion form compared to a lotion containing only 10% urea (without hemp extract) in relieving itching, increasing skin moisture, and reducing sleep disturbances caused by itching in scleroderma patients, as well as assessing any potential side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

10% urea lotion plus 1% cannabidiol

DRUG

Control

10% urea lotion

Locations (1)

Khon Kaen University

Khon Kaen, Thailand