Chronic PruritusPhase 2NCT06994520
Efficacy of Topical Cannabidiol for Eczema
A Phase 2 study testing Cannabidiol (CBD) and Triamcinolone (TAC) 0.1% cream in people with Chronic Pruritus and Eczema, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Itching is a common symptom encountered in general medical practice. It can cause significant discomfort, disrupt sleep, and impair patients' quality of life. Chronic pruritic skin conditions such as atopic dermatitis, nummular eczema, lichen simplex chronicus, and prurigo nodularis are frequently observed. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Chronic Pruritus, Eczema, Nummular Eczema
- What is being tested?
- Cannabidiol (CBD) and Triamcinolone (TAC) 0.1% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Phase 2
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants must be aged 25 years or older.
- Patients must be diagnosed with eczema, including atopic dermatitis, nummular eczema, lichen simplex chronicus, or prurigo nodularis, with pruritus persisting for more than 6 weeks.
- Patients must be willing to refrain from using other topical products throughout the 4-week study period.
- Patients must provide written informed consent to participate in the study.
Who cannot join
- Patients who have taken oral steroids, immunosuppressive drugs, or received phototherapy within the past 3 months.
- Patients with chronic kidney disease, liver cirrhosis, cancer, or thyroid disease.
- Pregnant or breastfeeding women, or women planning to become pregnant.
- Patients who develop erythematous itchy rash in response to an open patch test using cannabis extract products.
- Patients with a known allergy to cannabis-derived products, which may result from other ingredients and/or solvents used in the extraction process.
- Patients with severe or unstable cardio-pulmonary diseases (e.g., angina, peripheral vascular disease, cerebrovascular disease, or arrhythmia), or those at risk of cardiovascular disease.
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- Patients with a history of psychosis, current active mood disorder, or anxiety disorder.
- Patients who are addicted to substances, including nicotine, or are heavy alcohol users.
- Patients using other medications, particularly opioids or sedatives such as benzodiazepines.
- Patients taking medications known to potentially interact with cannabis extracts, such as warfarin, fluoroquinolones, or dihydropyridine calcium channel blockers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Topical Cannabidiol in Patients With Eczema
Itching is a common symptom encountered in general medical practice. It can cause significant discomfort, disrupt sleep, and impair patients' quality of life. Chronic pruritic skin conditions such as atopic dermatitis, nummular eczema, lichen simplex chronicus, and prurigo nodularis are frequently observed. The pathogenesis of these conditions remains incompletely understood, and effective long-term treatment options are limited. Current therapies include topical corticosteroids, topical calcineurin inhibitors, oral corticosteroids, and systemic immunosuppressants. However, these treatments are often associated with adverse effects, and the diseases tend to follow a chronic, relapsing course. Therefore, the investigators aim to investigate the efficacy and safety of topical cannabis extract in patients with chronic pruritic skin conditions.
- Conditions
- Chronic Pruritus, Eczema, Nummular Eczema, Atopic Dermatitis, Prurigo Nodularis
- Being tested
- Cannabidiol (CBD), Triamcinolone (TAC) 0.1% cream
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)Other
5%CBD cream
Triamcinolone (TAC) 0.1% creamDrug
comparator
| Study group | Role | What they receive |
|---|---|---|
| Cannabinoid | Experimental | Not described Receives: Other: Cannabidiol (CBD) |
| Triamcinolone cream | Active comparator | Not described Receives: Drug: Triamcinolone (TAC) 0.1% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease severity
Disease severity was evaluated using a composite scoring system that assessed four clinical signs-erythema, induration, scaling, and scratching-along with the extent of area involvement. Each sign was graded on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The extent of area involvement was classified into six categories based on the percentage of body surface area affected: 1 = less than 10%; 2 = 10-<30%; 3 = 30-<50%; 4 = 50-<70%; 5 = 70-<90%; 6 = 90-100%.
The overall severity score was obtained by summing the individual scores for erythema, induration, scaling, and dryness for each affected area and then multiplying this sum by the corresponding area involvement score. Higher total scores indicated greater disease severity.
Measured: 4 weeks
Changing of erythema
Erythema was graded on a scale from 0 to 3, with 0 indicating no redness, 1 mild, 2 moderate, and 3 severe redness.
Measured: 4 weeks
Changing of induration
Induration was graded on a scale from 0 to 3, with 0 indicating no induration, 1 mild, 2 moderate, and 3 severe skin thickening.
Measured: 4 weeks
Changing of scaling
Scaling (flaking of the skin) was graded on a scale from 0 to 3, with 0 indicating none, 1 mild, 2 moderate, and 3 severe.
Measured: 4 weeks
Changing of scratching
Excoriation (scratching marks) was graded on a scale from 0 to 3, with 0 indicating no excoriation, 1 mild, 2 moderate, and 3 severe excoriation.
Measured: 4 weeks
Itching severity
Itching severity was assessed using an 11-point numeric rating scale (NRS). The NRS-11 evaluates average intensity of pruritus ranging from 0 (no itch) to 10 (worst imaginable itch). Scores were classified into three groups as follows: 0-3 = mild, 4-7 = moderate, and 8-10 = severe.
Measured: 4 weeks
Secondary outcomes (1)
Adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 May 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PruritusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Topical cannabidiol versus 0.1% TA cream
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suteeraporn Chaowattanapanit, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994520
- Sponsor's protocol ID
- HE671500
- Status last verified
- Aug 2026
- First submitted
- 18 May 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Cannabidiol in Patients With Eczema
- ClinicalTrials.gov ID
- NCT06994520
- Acronym / sponsor ID
- HE671500
- Conditions
- Chronic Pruritus, Eczema, Nummular Eczema, Atopic Dermatitis, Prurigo Nodularis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 May 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 a common symptom encountered in general medical practice. It can cause significant discomfort, disrupt sleep, and impair patients' quality of life. Chronic pruritic skin conditions such as atopic dermatitis, nummular eczema, lichen simplex chronicus, and prurigo nodularis are frequently observed. The pathogenesis of these conditions remains incompletely understood, and effective long-term treatment options are limited. Current therapies include topical corticosteroids, topical calcineurin inhibitors, oral corticosteroids, and systemic immunosuppressants. However, these treatments are often associated with adverse effects, and the diseases tend to follow a chronic, relapsing course. Therefore, the investigators aim to investigate the efficacy and safety of topical cannabis extract in patients with chronic pruritic skin conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Topical cannabidiol versus 0.1% TA cream
| Arm | Type | Receives |
|---|---|---|
| Cannabinoid | Experimental | Other: Cannabidiol (CBD) |
| Triamcinolone cream | Active comparator | Drug: Triamcinolone (TAC) 0.1% cream |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All participants must be aged 25 years or older.
- Patients must be diagnosed with eczema, including atopic dermatitis, nummular eczema, lichen simplex chronicus, or prurigo nodularis, with pruritus persisting for more than 6 weeks.
- Patients must be willing to refrain from using other topical products throughout the 4-week study period.
- Patients must provide written informed consent to participate in the study.
Key exclusion criteria (10 listed)
- Patients who have taken oral steroids, immunosuppressive drugs, or received phototherapy within the past 3 months.
- Patients with chronic kidney disease, liver cirrhosis, cancer, or thyroid disease.
- Pregnant or breastfeeding women, or women planning to become pregnant.
- Patients who develop erythematous itchy rash in response to an open patch test using cannabis extract products.
- Patients with a known allergy to cannabis-derived products, which may result from other ingredients and/or solvents used in the extraction process.
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 |
|---|---|---|
| Cannabidiol (CBD)5%CBD cream | Other | Cannabinoid |
| Triamcinolone (TAC) 0.1% creamcomparator | Drug | Triamcinolone cream |
Primary outcome
Disease severity
Time frame: 4 weeks
Disease severity was evaluated using a composite scoring system that assessed four clinical signs-erythema, induration, scaling, and scratching-along with the extent of area involvement. Each sign was graded on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The extent of area involvement was classified into six categories based on the percentage of body surface area affected: 1 = less than 10%; 2 = 10-<30%; 3 = 30-<50%; 4 = 50-<70%; 5 = 70-<90%; 6 = 90-100%. The overall severity score was obtained by summing the individual scores for erythema, induration, scaling, and dryness for each affected area and then multiplying this sum by the corresponding area involvement score. Higher total scores indicated greater disease severity.
Changing of erythema
Time frame: 4 weeks
Erythema was graded on a scale from 0 to 3, with 0 indicating no redness, 1 mild, 2 moderate, and 3 severe redness.
Changing of induration
Time frame: 4 weeks
Induration was graded on a scale from 0 to 3, with 0 indicating no induration, 1 mild, 2 moderate, and 3 severe skin thickening.
Changing of scaling
Time frame: 4 weeks
Scaling (flaking of the skin) was graded on a scale from 0 to 3, with 0 indicating none, 1 mild, 2 moderate, and 3 severe.
Changing of scratching
Time frame: 4 weeks
Excoriation (scratching marks) was graded on a scale from 0 to 3, with 0 indicating no excoriation, 1 mild, 2 moderate, and 3 severe excoriation.
Itching severity
Time frame: 4 weeks
Itching severity was assessed using an 11-point numeric rating scale (NRS). The NRS-11 evaluates average intensity of pruritus ranging from 0 (no itch) to 10 (worst imaginable itch). Scores were classified into three groups as follows: 0-3 = mild, 4-7 = moderate, and 8-10 = severe.
1 secondary outcome
Adverse events
Time frame: 4 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 4 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol (CBD) and Triamcinolone (TAC) 0.1% cream in people with Chronic Pruritus and Eczema, 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 4 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 4 Aug 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease severity (time frame: 4 weeks). The study lists 6 primary outcomes in all. 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 4 Aug 2026.