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Table of Contents
Vol. 21, No. 1, 2008
Issue release date: January 2008
Section title: Original Paper
Skin Pharmacol Appl Skin Physiol 2008;21:39–45
(DOI:10.1159/000111134)

Placebo-Controlled, Double-Blind, Randomized, Prospective Study of a Glycerol-Based Emollient on Eczematous Skin in Atopic Dermatitis: Biophysical and Clinical Evaluation

Breternitz M.a · Kowatzki D.a · Langenauer M.b · Elsner P.a · Fluhr J.W.a
aSkin Physiology Laboratory, Department of Dermatology, Friedrich Schiller University, Jena, Germany; bSpirig Pharma AG, Egerkingen, Switzerland

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: March 15, 2007
Accepted: July 23, 2007
Published online: November 19, 2007
Issue release date: January 2008

Number of Print Pages: 7
Number of Figures: 4
Number of Tables: 1

ISSN: 1660-5527 (Print)
eISSN: 1660-5535 (Online)

For additional information: http://www.karger.com/SPP

Abstract

Background/Aims: Atopic dermatitis (AD) is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of AD are dry skin, intense pruritus and impaired epidermal barrier function. The therapeutic management of AD is difficult and needs individualized concepts. Moisturizing creams and emollients are useful and important treatment adjuncts for the daily skin care of patients with dry and inflamed skin, e.g. AD. Glycerol is known to increase stratum corneum (SC) hydration, improve epidermal barrier function and decrease clinical signs of inflammation. However, no controlled study on the efficacy of glycerol on barrier function and SC hydration in AD has been published. In the present study, a topical 20% glycerol preparation was compared with its vehicle in patients with AD. The aim of the present study was to evaluate the effect of a single emollient ingredient in AD within the full frame of a phase III drug study. Methods: 24 patients with AD were treated for 4 weeks twice daily with a glycerol-based emollient in a randomized, double-blind study. Transepidermal water loss, skin capacitance, erythema and skin surface pH were assessed with biophysical, non-invasive instruments. The SCORAD and a local severity score were evaluated. After a wash-out period of 2 weeks, these parameters were assessed in order to quantify the sustained effect of this treatment. Results: SC hydration was significantly improved, and epidermal barrier function was restored under treatment with glycerol-containing cream compared to the glycerol-free placebo. No significant differences were detectable for erythema values, SCORAD and local severity between the glycerol-containing cream and placebo. However, an improvement over time was detectable in the assessed parameters in both groups indicating the importance of emollient treatment in AD. Conclusions: Glycerol-based emollients have a positive influence on the skin of patients with AD. They enhance the SC hydration. Furthermore, it was possible to evaluate skin care products with a protocol design for efficacy studies of fully registered drugs in a placebo-controlled study.

© 2007 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: March 15, 2007
Accepted: July 23, 2007
Published online: November 19, 2007
Issue release date: January 2008

Number of Print Pages: 7
Number of Figures: 4
Number of Tables: 1

ISSN: 1660-5527 (Print)
eISSN: 1660-5535 (Online)

For additional information: http://www.karger.com/SPP


Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.