Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKhon Kaen University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Overlap with other connective tissue diseases

Pregnancy or lactation

Bedridden and confined to no self-care

Evidence of active malignant disease

Trial design

Design model

Crossover

Treatments tested in this trial

  • 10% urea lotion plus 1% cannabidiol

    Drug

    10% urea lotion plus 1% cannabidiol

  • Control

    Drug

    10% urea lotion

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: TreatmentExperimental treatment 1 intervention

Trial outcomes

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

Time frame
2 weeks

Secondary outcomes

1

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

Time frame
2 weeks
2

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

Time frame
2 weeks
3

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

Time frame
2 weeks
4

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

Time frame
2 weeks

Other outcomes

Sponsors and contacts

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