Pruritus secondary to atopic dermatitis Skin and Connective Tissue Diseases
Conditions
Interventions
Participants will be randomized to the active drug or a placebo with no active drug (2:1) via an IRT System and will apply the assigned study drug twice a day for up to 28 days. After the completion o
Sponsors
Praeventix, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18-69 years 2. Atopic dermatitis, diagnosed for at least the previous 6 months 3. Current atopic dermatitis investigator’s global assessment (vIGA-AD) >=2 at screening and baseline (Day 1). 4. Body surface area affected by AD 2-25% at baseline and screening, excluding palms, scalp, soles, genitals and intertriginous areas 5. Minimum Peak pruritus numeric rating scale (PP-NRS) at screening and baseline (Day 1) and averaged over the run-in period. 6. Use of effective contraception for those of reproductive potential or those with partners of reproductive potential
Exclusion criteria
Exclusion criteria: 1. Unstable course of atopic dermatitis, in the opinion of the Investigator 2. Use of oral antihistamines (H1 and/or H2 blockers); e.g. diphenhydramine, loratadine, fexofenadine, cetirizine, famotidine) within 14 days of first dose. 3. Use of other (non-antihistamine) nonbiologic systemic treatment for atopic dermatitis (e.g. cyclosporine, methotrexate) including ultraviolet light therapy, for atopic dermatitis in 2 months prior to baseline 4. Use of biologic therapies for atopic dermatitis within 3 months of screening 5. Treatment with topical medication for AD within 14 days prior to Day 1. 6. Emollient use between Day -1 (day before first dose) and Visit 6 (last day of dosing) on affected skin identified for treatment at Baseline (or subsequent visits). Stable bland emollient use is permitted during the treatment period on skin areas untreated with IMP. 7. The presence of a skin condition which, in the opinion of the investigator, would interfere with the interpretation of the results or conduct of the trial, including, but not limited to keloids, hypertrophic scars, or other clearly defined etiology for pruritus other than atopic dermatitis
Countries
New Zealand
Contacts
Public ContactCaroline O'Hara
Outcome results
None listed