Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma

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.

Inclusion 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

Exclusion criteria

• 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