Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Hydrocortisone Acetate 1% Cream
* Drug: Mometasone Furoate
* Drug: SNG100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females 6 years old or older with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist 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. Capable of complying with study requirements and study procedure. Investigator Global Assessment (IGA) of 3. The severity of atopic dermatitis will be defined as moderate by SCORAD range of 26-50 and EASI range of 7.1-21 points. Child-bearing potential women must use a proper contraception method. Exclusion Criteria: As determined by the study doctor, a medical history that may interfere with study objectives. Atopic dermatitis lesions that occur only on the face and scalp. Presence of a secondary infection with bacteria, fungi, or virus. Recent or current participation in another research study. Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study. Prior wound, tattoo, pigmentation or infection in the treated area.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNG100<br>Combination of low potency steroid with hydrating and moisturizing agents | Drug: SNG100<br>* A combination of low potency steroid and skin barrier repair agent<br>|
| Active Comparator: Hydrocortisone<br>This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). | Drug: Hydrocortisone Acetate 1% Cream<br>* Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.<br>|
| Active Comparator: Mometasone furoate<br>This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash. | Drug: Mometasone Furoate<br>* Mometasone is a medium-strength corticosteroid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | Within subject difference in response to topical product usability questionnaire items between trial treatments | 4 weeks |