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

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).

Informations de copyright

© 2023 The Authors. Skin Health and Disease published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Déclaration de conflit d'intérêts

L.S. has served as principal Investigator and/or sub‐Investigator for Eli Lilly, Abbvie, Pfizer, and has participated in advisory boards of Abbvie, Pfizer and Sanofi; S.G. has served as principal Investigator and/or sub‐Investigator for Eli Lilly, Abbvie, Pfizer and Amgene and also received honoraria and consultancy fees from Eli Lilly, Abbvie and Pfizer, Dexcel, Pierre Fabre and Padagis; R.D‐G. serves as consultant for Pfizer, Janssen, Sanofi, AbbVie, Novartis, La Roche‐Posay, Dexcel, Eli Lilly, Mii Labs and Padagis and served as principal Investigator and/or sub‐Investigator for Abbvie, Sanofi, Mii Labs and Regeneron; Y.R. serves as the CMO of Mii Labs, which develops SNG100, and has also received honoraria and consultancy fees from Eli Lilly, Abbvie, Novartis, Janssen, Neopharm, Giuliani S.p.A, Dexcel Pharma, Sanofi, Taro, Monasterium laboratories and Pfizer; E.S. serves as consultant for Pierre Fabre, Kamari, Biomx, Bayer, Amryt, Medison Pharma, Sol‐Gel, Krystal, BiondVax, Galmed, LaserTeam; I.Z., D.F. and O.Y.Z. work at Synergy dermatology Ltd.