臨床および実験皮膚科学研究ジャーナル
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概要

Efficacy of a Corticosteroid-Free, 5% Hyaluronic-Based Facial Cream in the Treatment of Seborrheic Dermatitis. A Proof-of-Concept Study

Massimo Milani, Antonio Barcella, Mario Puviani

Introduction: Seborrheic Dermatitis (SD) is a very common skin disease. This papulo-squamous disorder characterized by erythema, itch, and flaking, affects sebum-rich areas such as scalp, trunk and face. Topical steroids are commonly used as first line therapy of SD but their long-term use, especially when face is involved, could have untoward side effects like skin atrophy, acne and telangiectasia. Local tolerability and long-term safety concerns limit the use of calcineurin inhibitors. Hyaluronic acid topical formulations, thanks to its hydrating and several skin cellular modulation effects have shown to reduce skin inflammation and improve the clinical course of SD. A new cream formulation of HA 5% (Eutrosis DS, Difa Cooper, IFC Group; EDS) has been recently developed.
Study aim: To evaluate in a proof-of-concept study the efficacy and tolerability of EDS in the treatment of facial SD in adult subjects.
Subjects and Methods: A total of 20 out-patient male subjects (mean age 46) with moderate-severe facial SD were enrolled, after their informed consent, prospective 6-week assessor-blinded study. EDS cream was applied twice daily on the most affected areas (mainly face and chest). The primary outcome was the evolution of the Investigator Global Assessment (IGA) score evaluating erythema, scale/flaking, grade of seborrhea and itch, all measured on a five-point scale, from 0: absence of sign/symptom to 4: very severe sign/symptom. Subjects were assessed at baseline, after 3 and 6 weeks of treatment by an investigator unaware of the type of treatment. Local tolerability was evaluated checking self-reported side effects at each visit.
Results: All 20 subjects concluded the study. Baseline IGA scores (mean ± SD) was 9 ± 3 (range: 5-13). The use of EDS reduced significantly IGA score by 67% at week 3 and by 83% at week 6. EDS was effective in reducing erythema, scale, seborrhoea, and itch. The product was very well tolerated. No local side effects were reported.
Conclusion: EDS applied twice daily for 6 consecutive weeks has been shown to be effective in reducing signs and symptoms of SD of the face and chest. The product was found to be well tolerated. Future controlled trials are warranted to confirm the efficacy and safety of this new therapeutic corticosteroid-free, hyaluronic acid-based product for the treatment of facial SD.