Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.

Atopic Dermatitis Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04615962
• Other study ID #: CSP-001-SNG1
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 1, 2021
• Est. completion date: January 2022

Study information

• Verified date: October 2020
• Source: Seanergy Dermatology Ltd.
• Contact: Arik Tzour, PhD.
• Phone: 747366444
• Email: arik[@]miiscience.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Hydrocortisone Acetate 1% Cream
Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.
• Mometasone Furoate
Mometasone is a medium-strength corticosteroid.
• SNG100
A combination of low potency steroid and skin barrier repair agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seanergy Dermatology Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in the SCORAD index	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)	4 weeks
Other	Eczema Area and Severity Index (EASI) Score	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).	4 weeks
Other	NRS score	Itch Numeric Rating Scale. 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity.	4 weeks
Other	Investigator's Global Assessment (IGA) Score	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.	4 weeks
Primary	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	4 weeks
Secondary	Usability	Within subject difference in response to topical product usability questionnaire items between trial treatments	4 weeks