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New treatment option for Mediciine
Official title Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma
ClinicalTrials.gov ID: NCT07245238
What this study is testing
What is 10% urea lotion plus 1% cannabidiol?
10% urea lotion plus 1% cannabidiol is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for mediciine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- SSc patients aged between 18 and 70 years
- Diagnosed according to ACR/EULAR 2013 classification criteria
- Having chronic pruritus
- Must not receive steroid equivalent to prednisolone dose more than 10 mg/d
- Must receive a stable dose of steroid, immunosuppressant and/or vitamin or its supplement within 2 weeks before enrollment
You likely can't join if
- Overlap with other connective tissue diseases
- Pregnancy or lactation
- Bedridden and confined to no self-care
- Evidence of active malignant disease
- Present of uncontrolled or severe medical problems including diabetes mellitus, asthma, angina, cardiovascular, thyroid, hepatobiliary included...
- Present of active infection that needs systemic antibiotic
See the full eligibility criteria
- SSc patients aged between 18 and 70 years
- Diagnosed according to ACR/EULAR 2013 classification criteria
- Having chronic pruritus
- Must not receive steroid equivalent to prednisolone dose more than 10 mg/d
- Must receive a stable dose of steroid, immunosuppressant and/or vitamin or its supplement within 2 weeks before enrollment
- Must stop moisturizer treatment at least 1 week prior to randomization
- Must stop anxiolytics, hypnotics or sleeping pills at least 2 weeks before enrollment
- Understand and able to read and write Thai language
- Overlap with other connective tissue diseases
- Pregnancy or lactation
- Bedridden and confined to no self-care
- Evidence of active malignant disease
- 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)
- Present of active infection that needs systemic antibiotic
- Previous allergy to urea cream, cannabinoid or its derivatives
- Concomitant illegal drug used (amphetamine or its derivative, cocaine)
- On-going anxiolytics, hypnotics or sleeping pills used
- In a period that needs immunosuppressant dose adjustment
- Having history of schizophrenia, concurrent active mood disorder, or anxiety disorders
- Having dermatologic diseases causing pruritus such as atopic dermatitis, contact dermatitis, psoriasis, folliculitis, urticaria, lichen planus, bullous pemphigoid, dermatophytosis, pediculosis, scabies, cutaneous T cell...
- Having systemic diseases causing of pruritus other than SSc such as neurologic disease, polycythemia vera
The study team makes the final eligibility decision.
Where it's taking place
- Khon Kaen, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Khon Kaen, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.