A crosslinked polymer skin barrier film for moderate to severe atopic dermatitis: A pilot study in adults.


Journal

Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132

Informations de publication

Date de publication:
Apr 2020
Historique:
received: 21 05 2019
revised: 05 09 2019
accepted: 09 09 2019
pubmed: 8 10 2019
medline: 11 11 2020
entrez: 8 10 2019
Statut: ppublish

Résumé

Occlusive treatments are a mainstay in atopic dermatitis (AD) management but may not be well tolerated or lack compliance. A comfortable, semiocclusive, artificial skin barrier that is well tolerated, provides protection, and reduces water loss is needed. To evaluate the potential tolerability and therapeutic benefits of a crosslinked polymer layer (XPL) in adults with AD. A single-center, open-label pilot study was conducted involving 10 subjects with moderate to severe AD. Subjects applied XPL up to twice daily for 30 days on a selected treatment area. Investigator's Global Assessment, clinical signs of eczema, and pruritus were assessed on days 1, 3, 5, 15, and 30. Film durability and patient satisfaction were also evaluated. Investigator's Global Assessment scores improved from moderate to severe at baseline to clear to almost clear in 8 of 9 patients at day 30. Pruritus improved from trace to severe itching (baseline) to all subjects having trace to no itching at day 30. There was 1 adverse event of mild exudative dermatitis. The study was limited by small sample size, open-label design, and lack of control. XPL may be an effective adjuvant in AD treatment. A larger study with a control group is warranted.

Sections du résumé

BACKGROUND BACKGROUND
Occlusive treatments are a mainstay in atopic dermatitis (AD) management but may not be well tolerated or lack compliance. A comfortable, semiocclusive, artificial skin barrier that is well tolerated, provides protection, and reduces water loss is needed.
OBJECTIVE OBJECTIVE
To evaluate the potential tolerability and therapeutic benefits of a crosslinked polymer layer (XPL) in adults with AD.
METHODS METHODS
A single-center, open-label pilot study was conducted involving 10 subjects with moderate to severe AD. Subjects applied XPL up to twice daily for 30 days on a selected treatment area. Investigator's Global Assessment, clinical signs of eczema, and pruritus were assessed on days 1, 3, 5, 15, and 30. Film durability and patient satisfaction were also evaluated.
RESULTS RESULTS
Investigator's Global Assessment scores improved from moderate to severe at baseline to clear to almost clear in 8 of 9 patients at day 30. Pruritus improved from trace to severe itching (baseline) to all subjects having trace to no itching at day 30. There was 1 adverse event of mild exudative dermatitis.
LIMITATIONS CONCLUSIONS
The study was limited by small sample size, open-label design, and lack of control.
CONCLUSION CONCLUSIONS
XPL may be an effective adjuvant in AD treatment. A larger study with a control group is warranted.

Identifiants

pubmed: 31589946
pii: S0190-9622(19)32822-1
doi: 10.1016/j.jaad.2019.09.073
pii:
doi:

Substances chimiques

Cross-Linking Reagents 0
Polymers 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

895-901

Informations de copyright

Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Auteurs

Melaney Bouthillette (M)

Shiseido Americas Corporation, Cambridge, Massachusetts; Olivo Laboratories, LLC, Watertown, Massachusetts. Electronic address: mbouthillette@sac.shiseido.com.

Daniela Beccati (D)

Shiseido Americas Corporation, Cambridge, Massachusetts; Olivo Laboratories, LLC, Watertown, Massachusetts.

Ariya Akthakul (A)

Shiseido Americas Corporation, Cambridge, Massachusetts; Olivo Laboratories, LLC, Watertown, Massachusetts.

Nithin Ramadurai (N)

Shiseido Americas Corporation, Cambridge, Massachusetts; Olivo Laboratories, LLC, Watertown, Massachusetts.

Amir Nashat (A)

Olivo Laboratories, LLC, Watertown, Massachusetts.

Robert Langer (R)

Harvard-MIT Division of Health Science and Technology, Massachusetts Institute of Technology, Cambridge, Massachusetts; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts; David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts; Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts.

R Rox Anderson (RR)

Harvard-MIT Division of Health Science and Technology, Massachusetts Institute of Technology, Cambridge, Massachusetts; Wellman Center for Photomedicine, Massachusetts General Hospital, Boston, Massachusetts; Department of Dermatology, Harvard Medical School, Boston, Massachusetts.

Fernanda H Sakamoto (FH)

Wellman Center for Photomedicine, Massachusetts General Hospital, Boston, Massachusetts; Department of Dermatology, Harvard Medical School, Boston, Massachusetts. Electronic address: FSakamoto@mgh.harvard.edu.

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Classifications MeSH