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OpenTrials
Active, Not Recruiting

NCT Number: NCT06994520

Efficacy of Topical Cannabidiol for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Cannabidiol (CBD)

Other

5%CBD cream

Triamcinolone (TAC) 0.1% cream

Drug

comparator

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Adverse events

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Efficacy of Topical Cannabidiol in Patients With Eczema

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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