Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma (cannabidiol)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intervention Study; Systemic Sclerosis (SSc); Mediciine
• Intervention / Treatment: Drug: Control; Drug: 10% urea lotion plus 1% cannabidiol

Detailed Description

Systemic Sclerosis (SSc), also known as scleroderma, is a connective tissue disease primarily characterized by skin hardening. It can be classified into two main subgroups: limited cutaneous systemic sclerosis (lcSSc) and diffuse cutaneous systemic sclerosis (dcSSc), based on the extent of skin involvement.

Currently, there are no definitive studies on the efficacy of topical Cannabidiol (CBD) for treating pruritus in SSc patients. Furthermore, there is no standardized guideline for the management of pruritus in SSc in general. A 10% urea cream is commonly used to improve skin hydration and reduce itching.

This study aims to evaluate the efficacy of a lotion containing 10% urea combined with 1% CBD, formulated for ease of administration and a comfortable, non-greasy feel. This formulation will be compared against a lotion containing only 10% urea. The study will assess its effectiveness in relieving pruritus, improving skin hydration, and reducing sleep disturbances caused by itching in patients with systemic sclerosis. It will also evaluate any potential side effects.

Primary Objective

To compare the efficacy of a 10% urea lotion with 1% topical CBD (investigational group) versus a 10% urea lotion alone (control group) in alleviating pruritus in patients with systemic sclerosis.

Secondary Objectives

To compare the effects of the investigational and control groups on skin hydration.

To compare the effects of the investigational and control groups on skin melanin levels and erythema (redness).

To compare the effects of the investigational and control groups on sleep quality.

To compare the effects of the investigational and control groups on quality of life.

To assess the change in pruritus from baseline after two weeks of treatment. To evaluate adverse events associated with the use of the investigational and control products.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chingching Foocharoen, MD; Phone Number: 6643363746; Email: fching@kku.ac.th

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Recruiting
    • Khon Kaen University
    • Contact: Chingching Foocharoen, MD; Phone Number: 6643363746; Email: fching@kku.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. SSc patients aged between 18 and 70 years
2. Diagnosed according to ACR/EULAR 2013 classification criteria
3. Having chronic pruritus
4. Must not receive steroid equivalent to prednisolone dose more than 10 mg/d
5. Must receive a stable dose of steroid, immunosuppressant and/or vitamin or its supplement within 2 weeks before enrollment
6. Must stop moisturizer treatment at least 1 week prior to randomization
7. Must stop anxiolytics, hypnotics or sleeping pills at least 2 weeks before enrollment
8. Understand and able to read and write Thai language

Exclusion Criteria:

1. Overlap with other connective tissue diseases
2. Pregnancy or lactation
3. Bedridden and confined to no self-care
4. Evidence of active malignant disease
5. 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)
6. Present of active infection that needs systemic antibiotic
7. Previous allergy to urea cream, cannabinoid or its derivatives
8. Concomitant illegal drug used (amphetamine or its derivative, cocaine)
9. On-going anxiolytics, hypnotics or sleeping pills used
10. In a period that needs immunosuppressant dose adjustment
11. Having history of schizophrenia, concurrent active mood disorder, or anxiety disorders
12. 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
13. Having systemic diseases causing of pruritus other than SSc such as neurologic disease, polycythemia vera

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 10% urea lotion	Drug: Control; 10% urea lotion
Experimental: Treatment; 10% urea lotion plus 1% cannabidiol	Drug: 10% urea lotion plus 1% cannabidiol; 10% urea lotion plus 1% cannabidiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changing of course of pruritus evaluated by Dynamic Pruritus Score compared to baseline in each group	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	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	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	The changing of course of pruritus evaluated by Patient Benefit Index compared to baseline in each group	2 weeks

Collaborators and Investigators

• Sponsor: Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Sleep quality; Pruritus; systemic sclerosis; Cannabinoid; Cannabidiol; Crossover study design; Emollients; \Cannabidiol
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Connective Tissue Diseases; Skin Manifestations; Sleep Wake Disorders; Skin Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Scleroderma, Systemic; Pruritus; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Cannabidiol
• Other Study ID Numbers: Cannabidiol cream; Khon Kaen University (Other Grant/Funding Number: Khon Kaen University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No