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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
Khon Kaen University
RECRUITING
Khon Kaen
Contact Information
Primary
Chingching Foocharoen, MD
fching@kku.ac.th
6643363746
Time Frame
Start Date: 2025-11-05
Estimated Completion Date: 2028-12
Participants
Target number of participants: 36
Treatments
Active_comparator: Control
10% urea lotion
Experimental: Treatment
10% urea lotion plus 1% cannabidiol
Sponsors
Leads: Khon Kaen University

This content was sourced from clinicaltrials.gov

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