Atopic DermatitisPhase 1SNG100NCT04615962
Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.
A Phase 1 study testing Hydrocortisone Acetate 1% Cream, Mometasone Furoate and SNG100 in people with Atopic Dermatitis, run by Seanergy Dermatology Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Hydrocortisone Acetate 1% Cream, Mometasone Furoate and SNG100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Hydrocortisone Acetate 1% Cream, Mometasone Furoate, SNG100
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone Acetate 1% CreamDrug
Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.
Mometasone FuroateDrug
Mometasone is a medium-strength corticosteroid.
SNG100Drug
A combination of low potency steroid and skin barrier repair agent
| Study group | Role | What they receive |
|---|---|---|
| SNG100 | Experimental | Combination of low potency steroid with hydrating and moisturizing agents Receives: Drug: SNG100 |
| Hydrocortisone | Active comparator | This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Receives: Drug: Hydrocortisone Acetate 1% Cream |
| Mometasone furoate | Active comparator | This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash. Receives: Drug: Mometasone Furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (1)
Usability
Within subject difference in response to topical product usability questionnaire items between trial treatments
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Jan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seanergy Dermatology Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuval Ramot, Prof., Study director, Seanergy Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615962
- Sponsor's protocol ID
- CSP-001-SNG1
- Acronym
- SNG100
- Status last verified
- Oct 2020
- First submitted
- 25 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04615962
- Acronym / sponsor ID
- SNG100 / CSP-001-SNG1
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Seanergy Dermatology Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SNG100 | Experimental | Drug: SNG100Combination of low potency steroid with hydrating and moisturizing agents |
| Hydrocortisone | Active comparator | Drug: Hydrocortisone Acetate 1% CreamThis medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). |
| Mometasone furoate | Active comparator | Drug: Mometasone FuroateThis medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash. |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone Acetate 1% CreamHydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties. | Drug | Hydrocortisone |
| Mometasone FuroateMometasone is a medium-strength corticosteroid. | Drug | Mometasone furoate |
| SNG100A combination of low potency steroid and skin barrier repair agent | Drug | SNG100 |
Primary outcome
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
1 secondary outcome
Usability
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuval Ramot, Prof. study director
Seanergy Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydrocortisone Acetate 1% Cream, Mometasone Furoate and SNG100 in people with Atopic Dermatitis, run by Seanergy Dermatology Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arik Tzour, PhD. (747366444, arik@miiscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side Effects AE's and SAE's (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.