Topical Application of a Formulation Containing Pea Proteins and Xyloglucan in Adult Patients with Atopic Dermatitis: A Double-blind, Parallel, Randomized, Placebo-controlled, Multicenter Study

Mehedi Sowlati; Olguta-Anca Orzan; Silviu Horia Morariu; Zlatka Etropolska; Stefano Veraldi; Stefan Dimitrov

Topical Application of a Formulation Containing Pea Proteins and Xyloglucan in Adult Patients with Atopic Dermatitis: A Double-blind, Parallel, Randomized, Placebo-controlled, Multicenter Study

J Clin Aesthet Dermatol. 2023 Jul;16(7):35-41.

Authors

Mehedi Sowlati¹, Olguta-Anca Orzan², Silviu Horia Morariu³, Zlatka Etropolska⁴, Stefano Veraldi⁵, Stefan Dimitrov⁶

Affiliations

¹ Dr. Sowlati is with the County Clinical Emergency Hospital in Arad, Romania.
² Dr. Orzan is with Elias Emergency University Hospital in Romania.
³ Dr. Morariu is with County Clinical Hospital of Mures in Romania.
⁴ Dr. Etropolska is with the Ambulatory Practice for Primary Outpatient Medical Care SANA OOD in Bulgaria.
⁵ Dr. Veraldi is with the Department of Pathophysiology and Transplantation at Università degli Studi, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan, Italy.
⁶ Dr. Dimitrov is with the Medical center Prolet EOOD in Bulgaria.

PMID: 37560506
PMCID: PMC10409507

Abstract

Objective: Atopic dermatitis (AD) management requires long-term use of drugs that come with side effects. Compounds such as xyloglucan (XG) and pea proteins (PP) are emerging alternatives to corticosteroids that have shown to restore skin barrier function in preclinical studies. This double-blind, parallel, randomized, placebo-controlled clinical trial investigated the efficacy and safety of XG and PP, in adult AD patients.

Methods: Fourty-two patients with AD were randomly assigned 1:1 to receive a XG+PP treatment or the vehicle without XG+PP twice/day for 14 consecutive days for assessment at baseline, Day 8 and Day 15; follow-up visit was 14 days after the end of treatment (Day 28). Efficacy was evaluated using the Scoring Atopic Dermatitis (SCORAD) index, AD severity index (ADSI) score and patient-oriented eczema measure (POEM). Safety and tolerability were monitored as the occurrence of Adverse Events (AEs).

Results: At baseline, both groups exclusively included moderate/severe AD cases. At Day 8, six patients treated with XG+PP displayed complete resolution of AD, while 15 patients had mild AD. At Day 28, 16 patients no longer had eczema, whereas five patients displayed mild AD. Notably, 21 patients in the vehicle group still displayed moderate/severe AD.

Conclusion: XG and PP promote rapid and long-lasting relief, supporting its use as a safe alternative to mainstay corticosteroid treatments for AD management. The study protocol has been registered in the ISRCTN registry (TN66879853).

Keywords: ADSI; Atopic dermatitis; POEM; pea proteins; xyloglucan.