Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.

Phase 1

• Conditions: Atopic Dermatitis
• Interventions: Drug: SNG100; Drug: Hydrocortisone Acetate 1% Cream; Drug: Mometasone Furoate

• Registration Number: NCT04615962
• Lead Sponsor: Seanergy Dermatology Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-25
• Study First Submitted QC: 2020-10-29
• Last Update Submitted: 2020-10-29
• Study First Posted: 2020-11-04
• Last Update Posted: 2020-11-04
• Study Start: 2021-01-01
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SNG100	SNG100	Combination of low potency steroid with hydrating and moisturizing agents
Hydrocortisone	Hydrocortisone Acetate 1% Cream	This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash).
Mometasone furoate	Mometasone Furoate	This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Usability	4 weeks	Within subject difference in response to topical product usability questionnaire items between trial treatments