NCT07245238 Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma
| NCT ID | NCT07245238 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Khon Kaen University |
| Condition | Mediciine |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 36 participants in total. It began in 2025-11-05 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07245238 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Mediciine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07245238 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 36 participants.
Is NCT07245238 currently recruiting?
Yes, NCT07245238 is actively recruiting participants. Contact the research team at fching@kku.ac.th for enrollment information.
Where is the NCT07245238 trial being conducted?
This trial is being conducted at Khon Kaen, Thailand.
Who is sponsoring the NCT07245238 clinical trial?
NCT07245238 is sponsored by Khon Kaen University. The trial plans to enroll 36 participants.