Mediciine study: 10% urea lotion plus
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?
This is an investigational topical lotion being studied to see if it can help with itching in people with scleroderma. It is designed to increase skin moisture and reduce itching, though the exact way it works for this specific condition is still being learned.
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
- The study will see if the hemp‑urea lotion reduces itching, keeps skin moist, and improves sleep compared to urea alone.
- Who it's for
- Adults who have systemic sclerosis (scleroderma) and experience itching.
- What's involved
- Participants will apply the assigned lotion to itchy skin, keep a diary of itch and sleep, and attend clinic visits for skin checks and questionnaires.
- Time commitment
- The trial lasts several weeks, with regular clinic visits and daily lotion use at home.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Khon Kaen, Thailand. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.