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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabinoid | Experimental |
| |
| Triamcinolone cream | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol (CBD) | Other | 5%CBD cream |
| |
| Triamcinolone (TAC) 0.1% cream |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khon Kaen University | Khon Kaen | Changwat Khon Kaen | 40002 | Thailand |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Topical cannabidiol versus 0.1% TA cream
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| Drug |
comparator |
|
| 4 weeks |
| D012873 |
| Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011245 |
| Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |