Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
NCT Number: NCT03868098
This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (AD). In each subject four application areas will be identified. Each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. The areas will be randomly assigned to treatment with topical Crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Montreal, Quebec, H2X 2V1, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)
Other names: Eucrisa
Placebo ointment (vehicle)
Time frame: Baseline, Day 15
Change from baseline in TSS in target lesions treated with crisaborole ointment 2% or vehicle at Day 15.
Total Signs Score (TSS) of the lesion is the assessment of the severity of erythema, edema/papulation, excoriation, and lichenification. Each of these subscales is scored independently using the 4-point severity scale with a value range from 0 to 3; 0 is the minimum (best) and 3 is the maximum (worst). The total score is computed by the sum of each subscale where the total ranges from the minimum 0 (best) to the maximum 12 (worst).
Time frame: Baseline, Day 8, Day 15
Change from baseline in lesion severity as measured by TSS at Day 8 and Day 15
Total Signs Score (TSS) of the lesion is the assessment of the severity of erythema, edema/papulation, excoriation, and lichenification. Each of these subscales is scored independently using the 4-point severity scale with a value range from 0 to 3; 0 is the minimum (best) and 3 is the maximum (worst). The total score is computed by the sum of each subscale where the total ranges from the minimum 0 (best) to the maximum 12 (worst).
Time frame: Change from baseline in TAA at Day 8 and Day 15.
Change from baseline in TAA at Day 8 and Day 15
Innovaderm Research Inc.
Other
A Randomized, Double-Blind, Intra-Individual, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Different Application Rates of Topically Applied Crisaborole Ointment 2% in Adult Subjects With Mild to Moderate Atopic Dermatitis
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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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