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This study is a randomized, intraindividual study to evaluate the short-term efficacy of triamcinolone acetonide (Aristocort® C) in subjects with atopic dermatitis.
This study is being conducted to evaluate the short-term efficacy and effect of triamcinolone acetonide (Aristocort® C) on pruritus, skin biomarkers and skin parameters in subject with atopic dermatitis.
Approximately 20 subjects with atopic dermatitis will receive twice-daily topical application of triamcinolone acetonide (Aristocort® C) or vehicle in two different randomized areas for 3 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone Acetonide (Aristocort® C) | Active Comparator |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide (Aristocort® C) | Drug | On Day 1, Day 2, and Day 3, subjects will receive 2 applications of 3 mg/cm2 on the same lesional area, at an interval of approximately 12 ± 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pruritus NRS on AD lesions | The intensity of pruritus will be evaluated using a NRS by asking subjects to assign a numerical score to the worst level of itching at each application area in the past 12 hours, on a scale from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pruritus NRS on AD lesions | The intensity of pruritus will be evaluated using a NRS (Numeric Rating Scale) by asking subjects to assign a numerical score to the worst level of itching at each application area in the past 12 hours, on a scale from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch. | 12, 24, 36, 48, and 60 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bissonnette, MD | Innovaderm Research Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Intra-individual
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| Vehicle | Drug | On Day 1, Day 2, and Day 3, subjects will receive 2 applications of 3 mg/cm2 on the same lesional area, at an interval of approximately 12 ± 2 hours. |
|
| Change from baseline in skin biomarkers for AD | An untargeted biomarker approach with gene expression profile of treated and untreated skin samples will be performed. | Day 2, Day 3, and Day 4 |
| Change from baseline in TSS | The TSS (Total Sign Score) is an assessment of the severity of erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and dryness, each scored independently using the 4-point severity scale with a value range from 0 to 3 (clear to severe). The rating for each parameter is then summed to create a score ranging from 0 to 18. | Day 4 |
| Change from baseline in TAA | The TAA (Target Areas Assessment) is a 6-point scale with a value range from 0 to 5 (clear to very severe) used to evaluate AD severity at each site of study drugs application. | Day 4 |
| Change from baseline in lesion IGA | The lesion IGA (Investigator Global Assessment) is a 5-point scale with a value range from 0 to 4 (clear to severe) used for the assessment of each target lesion severity. | Day 4 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |