Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma

NCT07245238 | Recruiting Phase 3

• 2 other identifiers: Cannabidiol creamKhon Kaen University
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Mediciine; Systemic Sclerosis (SSc); Intervention Study

Keywords

systemic sclerosis; Cannabinoid; Emollients; Crossover study design; Randomized controlled trial; Sleep quality; Pruritus; \Cannabidiol; Cannabidiol

Outcome Measures

Primary Outcomes (1)

• The changing of intensity of pruritus evaluated by visual analogue scale (VAS) compared to baseline and a comparison between treatment and control group

  The changing of intensity of pruritus evaluated by visual analogue scale (VAS) compared to baseline and a comparison between treatment and control group

  2 weeks

Secondary Outcomes (4)

• The changing of course of pruritus evaluated by Dynamic Pruritus Score compared to baseline in each group

  2 weeks

• The changing of skin hydration evaluated by using the Corneometer CM 825 compared to baseline and a comparison between treatment and control at the same skin area

  2 weeks

• The changing of skin melanin content and erythema level evaluated by using the Mexameter MX 18 compared to baseline and a comparison between treatment and control at the same skin area

  2 weeks

• The changing of course of pruritus evaluated by Patient Benefit Index compared to baseline in each group

  2 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

10% urea lotion

Drug: Control

Treatment

EXPERIMENTAL

10% urea lotion plus 1% cannabidiol

Drug: 10% urea lotion plus 1% cannabidiol

Interventions

10% urea lotion plus 1% cannabidiol DRUG

10% urea lotion plus 1% cannabidiol

Treatment

Control DRUG

10% urea lotion

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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 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 lymphoma, sunburn, drug allergy or skin eruption
• Having systemic diseases causing of pruritus other than SSc such as neurologic disease, polycythemia vera

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen University

Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic; Sleep Initiation and Maintenance Disorders; Pruritus

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Chingching Foocharoen, MD

CONTACT

6643363746; fching@kku.ac.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 24, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

TH (1)