Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: SNG100 Combination of low potency steroid with hydrating and moisturizing agents |
Drug: SNG100
A combination of low potency steroid and skin barrier repair agent
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Active Comparator: Hydrocortisone This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). |
Drug: Hydrocortisone Acetate 1% Cream
Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.
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Active Comparator: Mometasone furoate This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash. |
Drug: Mometasone Furoate
Mometasone is a medium-strength corticosteroid.
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Outcome Measures
Primary Outcome Measures
- 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
- Usability [4 weeks]
Within subject difference in response to topical product usability questionnaire items between trial treatments
Other Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males or females 6 years old or older with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist
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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.
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Capable of complying with study requirements and study procedure.
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Investigator Global Assessment (IGA) of 3.
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The severity of atopic dermatitis will be defined as moderate by SCORAD range of 26-50 and EASI range of 7.1-21 points.
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Child-bearing potential women must use a proper contraception method.
Exclusion Criteria:
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As determined by the study doctor, a medical history that may interfere with study objectives.
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Atopic dermatitis lesions that occur only on the face and scalp.
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Presence of a secondary infection with bacteria, fungi, or virus.
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Recent or current participation in another research study.
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Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study.
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Prior wound, tattoo, pigmentation or infection in the treated area.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Seanergy Dermatology Ltd.
Investigators
- Study Director: Yuval Ramot, Prof., Seanergy Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSP-001-SNG1