Condition category
Skin and Connective Tissue Diseases
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
30/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Gibbs

ORCID ID

Contact details

Dermatological Sciences
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom
-
neil.gibbs@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7064

Study information

Scientific title

Investigating whether topical application of a non toxic molecule improves epidermal pH and barrier function in atopic dermatitis

Acronym

Study hypothesis

It is understood that the skin of people with atopic dermatitis (AD) does not act as an efficient barrier against chemicals and microbes that can enter the skin. One of the chemicals in the skin that may be important in barrier function is called Filaggrin. This study examines whether application of a naturally-occuring molecule onto the skin of people with AD may improve the barrier function of their skin.

Ethics approval

MREC, ref: 08/H1009/51

Study design

Single-centre randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology

Intervention

1. Intervention: Gel containing a naturally-occuring chemical onto the skin of one their forearms every day for 6 weeks
2. Control: On the other forearm they will be asked to apply the same cream/gel that doesn't contain any of the naturally-occuring molecule

Intervention type

Drug

Phase

Not Applicable

Drug names

Filaggrin

Primary outcome measures

Each week volunteers will be asked to complete a short questionnaire (POEM)

Secondary outcome measures

1. General skin condition using a well established scoring system for AD (SCORAD)
2. Skin barrier function transepidermal water loss (TEWL), measured at monthly intervals

Overall trial start date

01/09/2008

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned sample size: 20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2008

Recruitment end date

01/01/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Manchester
Manchester
M13 9PT
United Kingdom

Sponsor information

Organisation

Biotechnology and Biological Science Research Council (BBSRC) (UK)

Sponsor details

Colney Lane
Colney
Norwich
NR4 7UA
United Kingdom

Sponsor type

Research council

Website

http://www.bbsrc.ac.uk/

Funders

Funder type

Research council

Funder name

Biotechnology and Biological Sciences Research Council

Alternative name(s)

BBSRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator.