Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT07245238

Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma

Led by Khon Kaen University · Updated on 2025-11-24

36

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with systemic sclerosis aged between 18 and 70 years
  • Diagnosis confirmed by ACR/EULAR 2013 classification criteria
  • Presence of chronic itching
  • Steroid use not exceeding prednisolone 10 mg per day
  • Stable dose of steroids, immunosuppressants, vitamins, or supplements for at least 2 weeks before enrollment
  • Discontinued moisturizer treatment at least 1 week before randomization
  • Discontinued anxiolytics, hypnotics, or sleeping pills at least 2 weeks before enrollment
  • Able to read and write Thai language
Not Eligible

You will not qualify if you...

  • Having other connective tissue diseases overlapping with systemic sclerosis
  • Pregnant or breastfeeding
  • Bedridden or unable to care for self
  • Active cancer
  • Severe uncontrolled medical conditions such as diabetes, asthma, angina, cardiovascular, thyroid, liver, or kidney diseases (creatinine above 1.4 mg/dl)
  • Active infection requiring systemic antibiotics
  • Allergy to urea cream, cannabinoids, or their derivatives
  • Current use of illegal drugs like amphetamines or cocaine
  • Using anxiolytics, hypnotics, or sleeping pills currently
  • Need for immunosuppressant dose adjustment during the study
  • History of schizophrenia, active mood disorders, or anxiety disorders
  • Skin diseases causing itching other than systemic sclerosis
  • Other systemic diseases causing itching such as neurologic disease or polycythemia vera

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Khon Kaen University

Khon Kaen, Thailand, 40002

Actively Recruiting

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Research Team

C

Chingching Foocharoen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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