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Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.

NCT ID: NCT04615962

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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SNG100

Combination of low potency steroid with hydrating and moisturizing agents

Group Type EXPERIMENTAL

SNG100

Intervention Type DRUG

A combination of low potency steroid and skin barrier repair agent

Hydrocortisone

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

Group Type ACTIVE_COMPARATOR

Hydrocortisone Acetate 1% Cream

Intervention Type DRUG

Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.

Mometasone furoate

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

Group Type ACTIVE_COMPARATOR

Mometasone Furoate

Intervention Type DRUG

Mometasone is a medium-strength corticosteroid.

Interventions

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Hydrocortisone Acetate 1% Cream

Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.

Intervention Type DRUG

Mometasone Furoate

Mometasone is a medium-strength corticosteroid.

Intervention Type DRUG

SNG100

A combination of low potency steroid and skin barrier repair agent

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seanergy Dermatology Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuval Ramot, Prof.

Role: STUDY_DIRECTOR

Seanergy Ltd.

Central Contacts

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Arik Tzour, PhD.

Role: CONTACT

[email protected]
747366444

Inbal Ziv, Ms.

Role: CONTACT

[email protected]
+972747366444

Other Identifiers

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CSP-001-SNG1

Identifier Type: -

Identifier Source: org_study_id