Atopic Dermatitis
Conditions
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.
Interventions
DRUGHydrocortisone Acetate 1% Cream
Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.
DRUGMometasone Furoate
Mometasone is a medium-strength corticosteroid.
DRUGSNG100
A combination of low potency steroid and skin barrier repair agent
Sponsors
Seanergy Dermatology Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Usability | 4 weeks | Within subject difference in response to topical product usability questionnaire items between trial treatments |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactArik Tzour, PhD.
Backup ContactInbal Ziv, Ms.
Outcome results
None listed