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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNG100 | Experimental | Combination of low potency steroid with hydrating and moisturizing agents |
|
| Hydrocortisone | Active Comparator | This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). |
|
| Mometasone furoate | Active Comparator | This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone Acetate 1% Cream | Drug | Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Within subject difference in response to topical product usability questionnaire items between trial treatments | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Eczema Area and Severity Index (EASI) Score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arik Tzour, PhD. | Contact | 747366444 | arik@miiscience.com | |
| Inbal Ziv, Ms. | Contact | +972747366444 | Inbal@miiscience.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuval Ramot, Prof. | Seanergy Ltd. | Study Director |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C021650 | hydrocortisone acetate |
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Mometasone Furoate | Drug | Mometasone is a medium-strength corticosteroid. |
|
| SNG100 | Drug | A combination of low potency steroid and skin barrier repair agent |
|
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 |
| 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 |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |