Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.

Sponsor

Seanergy Dermatology Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04615962

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Hydrocortisone Acetate 1% Cream Drug: Mometasone Furoate Drug: SNG100	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SNG100 Combination of low potency steroid with hydrating and moisturizing agents	Drug: SNG100 A combination of low potency steroid and skin barrier repair agent
Active Comparator: Hydrocortisone This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash).	Drug: Hydrocortisone Acetate 1% Cream Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.
Active Comparator: Mometasone furoate This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash.	Drug: Mometasone Furoate Mometasone is a medium-strength corticosteroid.

Arm

Intervention/Treatment

Experimental: SNG100

Combination of low potency steroid with hydrating and moisturizing agents

Drug: SNG100

A combination of low potency steroid and skin barrier repair agent

Active Comparator: Hydrocortisone

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

Drug: Hydrocortisone Acetate 1% Cream

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

Active Comparator: Mometasone furoate

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

Drug: Mometasone Furoate

Mometasone is a medium-strength corticosteroid.

Outcome Measures

Primary Outcome Measures

Side Effects AE's and SAE's [4 weeks]
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 [4 weeks]
Within subject difference in response to topical product usability questionnaire items between trial treatments

Other Outcome Measures

Change from baseline in the SCORAD index [4 weeks]
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)
Eczema Area and Severity Index (EASI) Score [4 weeks]
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).
NRS score [4 weeks]
Itch Numeric Rating Scale. 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity.
Investigator's Global Assessment (IGA) Score [4 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.