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Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects. (SNG100)

Primary Purpose

Atopic Dermatitis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hydrocortisone Acetate 1% Cream
Mometasone Furoate
SNG100
Sponsored by
Seanergy Dermatology Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

6 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males or females 6 years old or older with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist
  2. Any child age 6 to 18 with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written informed consent must be given by parent/guardian.
  3. Capable of complying with study requirements and study procedure.
  4. Investigator Global Assessment (IGA) of 3.
  5. The severity of atopic dermatitis will be defined as moderate by SCORAD range of 26-50 and EASI range of 7.1-21 points.
  6. Child-bearing potential women must use a proper contraception method.

Exclusion Criteria:

  1. As determined by the study doctor, a medical history that may interfere with study objectives.
  2. Atopic dermatitis lesions that occur only on the face and scalp.
  3. Presence of a secondary infection with bacteria, fungi, or virus.
  4. Recent or current participation in another research study.
  5. Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study.
  6. Prior wound, tattoo, pigmentation or infection in the treated area.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    SNG100

    Hydrocortisone

    Mometasone furoate

    Arm Description

    Combination of low potency steroid with hydrating and moisturizing agents

    This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash).

    This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash.

    Outcomes

    Primary Outcome Measures

    Side Effects AE's and SAE's
    Evaluate safety and tolerability as measured by completion of a full prescribed treatment course, treatment interruptions, SAE's and AE's

    Secondary Outcome Measures

    Usability
    Within subject difference in response to topical product usability questionnaire items between trial treatments

    Full Information

    First Posted
    October 25, 2020
    Last Updated
    October 29, 2020
    Sponsor
    Seanergy Dermatology Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04615962
    Brief Title
    Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.
    Acronym
    SNG100
    Official Title
    A Phase I, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability Profile of Topical Cream SNG100 for 14 Days of Treatment in Moderate Atopic Dermatitis Subjects.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    January 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seanergy Dermatology Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators aimed to understand better the efficacy in a randomized, double-blind, intraindividual design trial in 66 participants with AD treated with SNG100, and 2 different strengths of topical steroids hydrocortisone and the medium potent mometasone furoate cream.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SNG100
    Arm Type
    Experimental
    Arm Description
    Combination of low potency steroid with hydrating and moisturizing agents
    Arm Title
    Hydrocortisone
    Arm Type
    Active Comparator
    Arm Description
    This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash).
    Arm Title
    Mometasone furoate
    Arm Type
    Active Comparator
    Arm Description
    This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrocortisone Acetate 1% Cream
    Intervention Description
    Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.
    Intervention Type
    Drug
    Intervention Name(s)
    Mometasone Furoate
    Intervention Description
    Mometasone is a medium-strength corticosteroid.
    Intervention Type
    Drug
    Intervention Name(s)
    SNG100
    Intervention Description
    A combination of low potency steroid and skin barrier repair agent
    Primary Outcome Measure Information:
    Title
    Side Effects AE's and SAE's
    Description
    Evaluate safety and tolerability as measured by completion of a full prescribed treatment course, treatment interruptions, SAE's and AE's
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Usability
    Description
    Within subject difference in response to topical product usability questionnaire items between trial treatments
    Time Frame
    4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Change from baseline in the SCORAD index
    Description
    SCORAD: SCOring of Atopic Dermatitis Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)
    Time Frame
    4 weeks
    Title
    Eczema Area and Severity Index (EASI) Score
    Description
    The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).
    Time Frame
    4 weeks
    Title
    NRS score
    Description
    Itch Numeric Rating Scale. 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity.
    Time Frame
    4 weeks
    Title
    Investigator's Global Assessment (IGA) Score
    Description
    The IGA measures the investigator's global assessment of the participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males or females 6 years old or older with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist Any child age 6 to 18 with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written informed consent must be given by parent/guardian. Capable of complying with study requirements and study procedure. Investigator Global Assessment (IGA) of 3. The severity of atopic dermatitis will be defined as moderate by SCORAD range of 26-50 and EASI range of 7.1-21 points. Child-bearing potential women must use a proper contraception method. Exclusion Criteria: As determined by the study doctor, a medical history that may interfere with study objectives. Atopic dermatitis lesions that occur only on the face and scalp. Presence of a secondary infection with bacteria, fungi, or virus. Recent or current participation in another research study. Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study. Prior wound, tattoo, pigmentation or infection in the treated area.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arik Tzour, PhD.
    Phone
    747366444
    Email
    arik@miiscience.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Inbal Ziv, Ms.
    Phone
    +972747366444
    Email
    Inbal@miiscience.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuval Ramot, Prof.
    Organizational Affiliation
    Seanergy Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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