Topical doxycycline monohydrate hydrogel 1% targeting proteases/PAR2 pathway is a novel therapeutic for atopic dermatitis

Atopic Dermatitis (AD) is characterized by skin barrier disruption and an aberrant immune response. Doxycycline is tetracycline antibiotics broadly used systemically to treat inflammatory dermatologic conditions. Several studies have shown doxycycline has anti‐inflammatory and pro‐healing properties...

Full description

Saved in:
Bibliographic Details
Published inExperimental dermatology Vol. 29; no. 12; pp. 1171 - 1175
Main Authors Bohannon, Mary, Liu, Mingjin, Nadeau, Peter, Talton, Judy, Gibson, Daniel, Datta, Susmita, Schultz, Gregory, Talton, James, De Benedetto, Anna
Format Journal Article
LanguageEnglish
Published Denmark Wiley Subscription Services, Inc 01.12.2020
Subjects
Antibiotics
Atopic dermatitis
clinical trial
Dermatitis
Doxycycline
Eczema
Hydrogels
Hypotheses
Immune response
Inflammation
KLK5
proteases
Proteolysis
Pruritus
skin barrier
clinical trial
KLK5
skin barrier
atopic dermatitis
doxycycline
proteases
Online AccessGet full text

Cover

More Information
Summary:Atopic Dermatitis (AD) is characterized by skin barrier disruption and an aberrant immune response. Doxycycline is tetracycline antibiotics broadly used systemically to treat inflammatory dermatologic conditions. Several studies have shown doxycycline has anti‐inflammatory and pro‐healing properties, mainly by blocking tissue proteolytic activity. It is our hypothesis that daily application of a novel doxycycline topical formulation in AD subjects will reduce severity of the disease, by blocking cutaneous proteases activity and restoring skin barrier function and inflammation. To test this hypothesis, we performed a proof of concept, open‐label clinical study. Subjects enrolled in the study (n = 15) applied NanoDOX® Hydrogel 1% daily for 4 weeks on a chosen eczematous area. Investigational drug was well tolerated, and no local or systemic adverse events due to investigational drug were reported. Notably, a significant clinical improvement was observed based on a modified Eczema Area & Severity Index (EASI) score of the treated area from start of treatment to 14 and 28 days post‐treatment (P < .001). A significant improvement of pruritus was also observed (P = .02). This proof of concept clinical trial is first to explore the impact of a non‐systemic doxycycline treatment on AD patients. Our results provide evidence to investigate novel AD treatment strategies targeting cutaneous proteases activity.
Bibliography:Funding information
Clinical trial Registration: NCT02910011
Research reported in this publication was supported by Alchem Laboratories Corp, Alachua (FL; provided investigational drug) and the University of Florida Clinical and Translational Science Institute, which is supported in part by the NIH National Center for Advancing Translational Sciences under award number UL1TR001427. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
content type line 23
ADB, DG wrote the paper
ML, SD analyzed the data
ADB, PN, MB performed the research
Author Contributions Statement: All authors have read the manuscript and have approved submission. The data that support the findings of this study are available from the corresponding author upon reasonable request.
JT contributed essential reagents or tools
ADB, MB, JT, JT, GS, DG designed the research study
ISSN:0906-6705
1600-0625
1600-0625
DOI:10.1111/exd.14201