MediciinePhase 3cannabidiolNCT07245238
Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma
A Phase 3 study testing 10% urea lotion plus 1% cannabidiol in people with Mediciine and Systemic Sclerosis (SSc), run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mediciine, Systemic Sclerosis (SSc), Intervention Study
- What is being tested?
- 10% urea lotion plus 1% cannabidiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- 5 Nov 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Khon Kaen University
Khon Kaen, 40002
Chingching Foocharoen, MD, 6643363746, fching@kku.ac.th
About this study
Official title: 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.
Read the 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.
- Conditions
- Mediciine, Systemic Sclerosis (SSc), Intervention Study
- Being tested
- 10% urea lotion plus 1% cannabidiol, Control
- Keywords
- systemic sclerosis, Cannabinoid, Emollients, Crossover study design, Randomized controlled trial, Sleep quality, Pruritus, \Cannabidiol, Cannabidiol
- Medical subject headings
- Scleroderma, Systemic, Sleep Initiation and Maintenance Disorders, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% urea lotion plus 1% cannabidiolDrug
10% urea lotion plus 1% cannabidiol
ControlDrug
10% urea lotion
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 10% urea lotion Receives: Drug: Control |
| Treatment | Experimental | 10% urea lotion plus 1% cannabidiol Receives: Drug: 10% urea lotion plus 1% cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start5 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MediciineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chingching Foocharoen, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245238
- Sponsor's protocol ID
- Cannabidiol cream
- Other IDs
- Khon Kaen University
- Acronym
- cannabidiol
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07245238
- Acronym / sponsor ID
- cannabidiol / Cannabidiol cream
- Conditions
- Mediciine, Systemic Sclerosis (SSc), Intervention Study
- Keywords
- systemic sclerosis, Cannabinoid, Emollients, Crossover study design, Randomized controlled trial, Sleep quality, Pruritus, \Cannabidiol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Control10% urea lotion |
| Treatment | Experimental | Drug: 10% urea lotion plus 1% cannabidiol10% urea lotion plus 1% cannabidiol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% urea lotion plus 1% cannabidiol10% urea lotion plus 1% cannabidiol | Drug | Treatment |
| Control10% urea lotion | Drug | Control |
Primary outcome
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
The changing of intensity of pruritus evaluated by visual analogue scale (VAS) compared to baseline and a comparison between treatment and control group
4 secondary outcomes
The changing of course of pruritus evaluated by Dynamic Pruritus Score compared to baseline in each group
Time frame: 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
Time frame: 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
Time frame: 2 weeks
The changing of course of pruritus evaluated by Patient Benefit Index compared to baseline in each group
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10% urea lotion plus 1% cannabidiol in people with Mediciine and Systemic Sclerosis (SSc), run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chingching Foocharoen, MD (6643363746, fching@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.