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Trial record 58 of 159 for:    Recruiting, Not yet recruiting, Available Studies | "Eczema"

Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03351777
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Realm Therapeutics, Inc.

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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: PR022 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: PR022 topical gel, 0.05%
Applied twice daily for 28 days
Drug: PR022
Topical Gel

Experimental: PR022 topical gel, 0.1%
Applied twice daily for 28 days
Drug: PR022
Topical Gel

Placebo Comparator: PR022 topical gel vehicle
Applied twice daily for 28 days
Drug: PR022
Topical Gel




Primary Outcome Measures :
  1. Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI) [ Time Frame: 29 days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 29 Days ]
  2. Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29 [ Time Frame: 29 Days ]
  3. Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29 [ Time Frame: 29 Days ]
  4. Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29 [ Time Frame: 29 Days ]
  5. Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD [ Time Frame: 29 Days ]
  6. Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD) [ Time Frame: 29 Days ]
  7. Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS) [ Time Frame: 29 Days ]
  8. Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale [ Time Frame: 29 days ]
  9. Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI) [ Time Frame: 29 days ]
  10. 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 [ Time Frame: 29 Days ]

Other Outcome Measures:
  1. Change in serum IgE titer and TARC concentration from Baseline to Day 29 [ Time Frame: 29 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351777


Contacts
Contact: Valerie Crossley 4843212700 Valerie@realmtx.com
Contact: Kathy Goin kgoin@realmtx.com

Locations
United States, Pennsylvania
Principal Investigator Recruiting
Philadelphia, Pennsylvania, United States, 19148
Contact: Principal Investigator         
Sponsors and Collaborators
Realm Therapeutics, Inc.
Investigators
Study Director: Christian Peters, MD, PhD Realm

Responsible Party: Realm Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03351777     History of Changes
Other Study ID Numbers: REALM-1
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases