- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04615962
Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects. (SNG100)
October 29, 2020 updated by: Seanergy Dermatology Ltd.
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.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
66
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arik Tzour, PhD.
- Phone Number: 747366444
- Email: arik@miiscience.com
Study Contact Backup
- Name: Inbal Ziv, Ms.
- Phone Number: +972747366444
- Email: Inbal@miiscience.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SNG100
Combination of low potency steroid with hydrating and moisturizing agents
|
A combination of low potency steroid and skin barrier repair agent
|
Active Comparator: Hydrocortisone
This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash).
|
Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.
|
Active Comparator: Mometasone furoate
This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash.
|
Mometasone is a medium-strength corticosteroid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side Effects AE's and SAE's
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
Within subject difference in response to topical product usability questionnaire items between trial treatments
|
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in the SCORAD index
Time Frame: 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) |
4 weeks
|
Eczema Area and Severity Index (EASI) Score
Time Frame: 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).
|
4 weeks
|
NRS score
Time Frame: 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.
|
4 weeks
|
Investigator's Global Assessment (IGA) Score
Time Frame: 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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yuval Ramot, Prof., Seanergy Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2021
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
October 25, 2020
First Submitted That Met QC Criteria
October 29, 2020
First Posted (Actual)
November 4, 2020
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
October 29, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Eczema
- Dermatitis, Atopic
- Anti-Inflammatory Agents
- Dermatologic Agents
- Anti-Allergic Agents
- Mometasone Furoate
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
Other Study ID Numbers
- CSP-001-SNG1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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