Evidence map›Paper›PMID 29511936›Full record

ArticleDermatology and therapy2018

Efficacy and Tolerability of a Medical Device Repairing Emollient Cream Associated with a Topical Corticosteroid in Adults with Atopic Dermatitis: An Open-label, Intra-individual Randomized Controlled Study.

Ana Beatris Rossi, Adeline Bacquey, Thérèse Nocera, Marie-Dominique Thouvenin

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

Ana Beatris RossiClinical Skin Research and Development Center, Pierre Fabre Dermo-Cosmétique, 2 Rue Viguerie, Hotel Dieu, Toulouse, France.
Adeline BacqueyClinical Skin Research and Development Center, Pierre Fabre Dermo-Cosmétique, 2 Rue Viguerie, Hotel Dieu, Toulouse, France.
Thérèse NoceraClinical Skin Research and Development Center, Pierre Fabre Dermo-Cosmétique, 2 Rue Viguerie, Hotel Dieu, Toulouse, France.
Marie-Dominique ThouveninClinical Skin Research and Development Center, Pierre Fabre Dermo-Cosmétique, 2 Rue Viguerie, Hotel Dieu, Toulouse, France. marie.dominique.thouvenin@pierre-fabre.com.
Hôpital Larrey · FRPierre Fabre (France) · FRSkin Research Center · FR

Funding

Laboratoires Dermatologiques Ducray, Pierre Fabre, France NA
6 · The paper itself

Abstract

introductionMedical device repairing emollient creams (MDRECs) are designed to repair and protect the skin barrier. In this study, we examined the added clinical benefit and tolerability of a MDREC when used in association with a moderately potent topical corticosteroid (TCS) for adults with atopic dermatitis (AD).

methodsThis was an intra-individual randomized controlled trial in adults with moderate to severe AD (EudraCT no. 2014-002,194-10). Symmetrical lesions on each arm of the subjects were randomized to treatment for 10 days with twice-daily TCS (desonide) cream alone or with combined TCS + MDREC. Subjects were then included in a following 2-week maintenance phase if the AD on at least one test area had sufficiently improved so that the treatment was no longer needed. During the maintenance phase, treatment with the TCS cream was stopped, but twice-daily application of the MDREC was continued on the same test area previously assigned to receive it. The primary outcome measure was the change in local Scoring Atopic Dermatitis (SCORAD) index between day 1 and 3 based on investigators' assessment. Secondary measures of lesion severity included changes in the local patient-oriented SCORAD index, pruritus intensity according to subjects' assessments, and global assessments by subjects and investigators.

resultsThe study included 54 subjects. The change in investigator-observed local SCORAD index between day 1 and 3 was - 14.4% with TCS alone and - 24.5% for TCS + MDREC (p = 0.0005). Between baseline and the end of the treatment phase, all secondary measures of lesion severity decreased more with the combined TCS + MDREC treatment than with the TCS cream alone. The MDREC also reduced the relapse of AD lesions during the maintenance phase. Tolerability was very good, and the product was well accepted by subjects.

conclusionThese results support using the MDREC in association with TCS during AD flares and as a maintenance therapy after treatment with TCS has stopped.

fundingLaboratoires Dermatologiques Ducray, Pierre Fabre.

Indexed as

Atopic dermatitisClinical trialCorticosteroidDermatologyDexyane MeDEmollientTopical

Identifiers

PMID29511936
PMCPMC6002316
OpenAlexW2789702002

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.