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

ISRCTN	ISRCTN97515110
DOI	https://doi.org/10.1186/ISRCTN97515110
Secondary identifying numbers	7064

Submission date: 21/10/2010
Registration date: 21/10/2010
Last edited: 30/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Neil Gibbs
Scientific

Dermatological Sciences
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom

Email	neil.gibbs@manchester.ac.uk

Study information

Study design	Single-centre randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Investigating whether topical application of a non toxic molecule improves epidermal pH and barrier function in atopic dermatitis
Study objectives	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(s)	MREC, ref: 08/H1009/51
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Filaggrin
Primary outcome measure	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 study start date	01/09/2008
Completion date	01/01/2011

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Planned sample size: 20
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2008
Date of final enrolment	01/01/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The University of Manchester

Manchester
M13 9PT
United Kingdom

Sponsor information

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

Colney Lane
Colney
Norwich
NR4 7UA
United Kingdom

Website	http://www.bbsrc.ac.uk/
"ROR"	https://ror.org/00cwqg982

Funders

Funder type

Research council

Biotechnology and Biological Sciences Research Council
Government organisation / National government

Alternative name(s): UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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