Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.

Seanergy Dermatology

Status and phase: Unknown; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: Hydrocortisone Acetate 1% Cream; Drug: SNG100; Drug: Mometasone Furoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04615962

CSP-001-SNG1

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 6 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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66 participants in 3 patient groups

SNG100

Experimental group

Description:

Combination of low potency steroid with hydrating and moisturizing agents

Treatment:

Drug: SNG100

Hydrocortisone

Active Comparator group

Description:

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

Treatment:

Drug: Hydrocortisone Acetate 1% Cream

Mometasone furoate

Active Comparator group

Description:

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

Treatment:

Drug: Mometasone Furoate