Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.

• Status: Not yet recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seanergy Dermatology Ltd.
• Treatments: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Mometasone Furoate

Criteria

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.