Evidence map›Paper›PMID 38047249›Full record

ArticleSkin health and disease2023

SNG100, a novel topical treatment for moderate atopic dermatitis, in patients aged 6 years or older: A randomised, double-blind, active-controlled trial.

Liat Samuelov, Avner Shemer, Shoshana Greenberger, Inbal Ziv, Doron Friedman, Oron Yacoby-Zeevi, Roni Dodiuk-Gad, Yuval Ramot, Sari Murad, Eli Sprecher

Registry-linked trialAbstract read
In one paragraph

Article in Skin health and disease, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04615962 (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.), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04615962 phase1unknown statusnot on this map

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.

TypeinterventionalSponsorSeanergy Dermatology Ltd.Ran2021 to 2022Enrolled66ConditionsAtopic DermatitisArmsHydrocortisone Acetate 1% Cream, Mometasone Furoate, SNG100
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Liat SamuelovDivision of Dermatology Tel Aviv Sourasky Medical Center Tel Aviv Israel.
Avner ShemerFaculty of Medicine Tel Aviv University Tel Aviv Israel.
Shoshana GreenbergerFaculty of Medicine Tel Aviv University Tel Aviv Israel.ORCID https://orcid.org/0000-0001-8308-2790
Inbal ZivSeanergy Dermatology Rehovot Israel.
Doron FriedmanSeanergy Dermatology Rehovot Israel.
Oron Yacoby-ZeeviSeanergy Dermatology Rehovot Israel.
Roni Dodiuk-GadDermatology and Venereology Department Emek Medical Center Afula Israel.
Yuval RamotDepartment of Dermatology Hadassah-Hebrew University Medical Center Jerusalem Israel.
Sari MuradDepartment of Dermatology Hadassah-Hebrew University Medical Center Jerusalem Israel.
Eli SprecherDivision of Dermatology Tel Aviv Sourasky Medical Center Tel Aviv Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Atopic dermatitis (AD) is one of the most common inflammatory skin diseases. It is associated with significant itch and impaired quality of life. Systemic treatments are efficient but associated with side effects. Novel topical treatments with a favourable safety profile are needed. SNG100 is a novel composition of hydrocortisone 1% in a cream base comprising sulphated polysaccharide (SPS; extracted from in-house cultivated Porphyridium Cruentum unicellular algae), a well-known hydrating, moisturising and a skin barrier repairing agent. Objectives: To assess the safety, usability and efficacy of SNG100 cream in patients aged ≥6 years with moderate AD. Methods: In this proof of concept phase I, double-blind, randomised trial, participants received one of three treatments for 14 days: SNG100 twice daily (BID), hydrocortisone 1% BID or mometasone furoate once daily (QD). The primary endpoint was the safety and tolerability of SNG100 cream compared to hydrocortisone 1% and mometasone furoate. The secondary endpoint was the subject's usability of SNG100. Exploratory efficacy endpoints included percent change from baseline in SCOring AD (SCORAD), Eczema Area and Severity Index, Patient-Oriented Eczema Measure, Dermatology Life Quality Index, pruritus Numerical Rating Score (NRS), peak pruritus-NRS and Investigator's Global Assessment. Subjects were also followed up without any treatment for additional 14 days. Results: Overall, 66 participants were screened, and 60 patients were randomised. SNG100 demonstrated a high safety profile, similar to marketed products hydrocortisone 1% and mometasone furoate 0.1%, with no unanticipated drug safety related events. SNG100 and mometasone furoate 0.1% cream achieved almost similar and statistically significant greater percentage reductions from baseline in SCORAD as compared to hydrocortisone 1% cream. SNG100 demonstrated significant improvement in NRS as compared to hydrocortisone 1% cream. Remarkably, SNG100 led to a lasting effect with only 29.4% of subjects returning to IGA3 during the follow-up period compared to 50% and 38.9% in the hydrocortisone 1% and in mometasone furoate treatment arms, respectively. Conclusions: Topical SNG100 is an effective, safe, and well-tolerated innovative treatment for moderate AD. Trial registration number: NCT04615962 (Topical Cream SNG100 for Treatment in Moderate AD Subjects).

Identifiers

PMID38047249
PMCPMC10690700

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.