Clinical trial NCT03351777: Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis
Official title: Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Realm Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

* Male or female subjects 18 to 65 years of age
* EASI score ≤ 21 at baseline
* Diagnosis of mild-to-moderate (grade 2 or 3) AD according to the ISGA scale at Baseline
* BSA affected by AD: 5% to 20% at start of treatment
* Willing and able to apply study treatments as directed, comply with study instructions, and commit to attending all visits
* Willing and able to provide informed consent
* Use of adequate birth control, if of reproductive potential and sexually active

Exclusion Criteria:

* Widespread AD requiring systemic therapy
* Use of any of the following treatments within the specified time periods prior to Day 1
* Topical medications (topical antibiotics, topical corticosteroids, topical antifungals, topical antihistamines, topical retinoids, topical calcipotriene, tacrolimus, pimecrolimus, or other topical drug products for treatment of AD) or bleach bath within 2 weeks prior to Day 1
* Systemic agents (cyclosporine, systemic corticosteroids \[oral and injectable; intranasal and inhaled corticosteroids are allowed if use is kept constant during the study\], systemic antibiotics, immunomodulators or immunosuppressive therapies, interferon, cytotoxic drugs \[e.g., methotrexate, cyclophosphamide, azathioprine\], oral retinoids, systemic antifungals, tacrolimus) for the treatment of AD within 4 weeks prior to Day 1
* Ultraviolet (UV) therapy or use of a tanning booth/parlor within 6 weeks prior to Day 1
* Biologic therapies within 12 weeks (or 5 half-lives) prior to Day 1
* Antihistamines within 5 days prior to Day 1 \[stable regimens (consistent use ≥ 14 days before Day 1) of oral H1 antihistamines for non-AD lesion treatment will be allowed\]
* Active or potentially recurrent dermatologic condition other than AD that may confound evaluation
* Congenital ichthyosis (note that subjects with ichthyosis vulgaris are permitted)
* Known allergy to any ingredients of the investigational product formulation
* Significant confounding conditions as assessed by Investigator
* Any condition that could interfere with any evaluation in the study
* Pregnancy or breast feeding
* Any reason which, in the opinion of the Investigator, interferes with the ability of the subject to participate in or complete the trial

Primary outcomes:
measure: Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI)
timeFrame: 29 days
Secondary outcomes:
measure: Percentage of subjects who achieved success in Investigator's Static Global Assessment (ISGA), defined as a score of "Clear" (0) or "Almost Clear" (1) with a minimum 2-grade improvement at Day 29
timeFrame: 29 Days
measure: Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29
timeFrame: 29 Days
measure: Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29
timeFrame: 29 Days
measure: Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29
timeFrame: 29 Days
measure: Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD
timeFrame: 29 Days
measure: Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD)
timeFrame: 29 Days
measure: Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS)
timeFrame: 29 Days
measure: Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale
timeFrame: 29 days
measure: Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI)
timeFrame: 29 days
measure: Frequency counts and percentages of DLQI scores (scored 0 to 3) at Baseline and Day 29, as well as shift in DLQI scores from Baseline to Day 29
timeFrame: 29 Days
Other outcomes:
measure: Change in serum IgE titer and TARC concentration from Baseline to Day 29
timeFrame: 29 days
Locations:
city: Philadelphia
country: United States
facility: Principal Investigator
state: Pennsylvania
Study officials:
affiliation: Realm
name: Christian Peters, MD, PhD
role: STUDY_DIRECTOR
References: