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 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 trial start date
01/09/2008
Overall trial end date
01/01/2011
Reason abandoned (if study stopped)
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
Funders
Funder type
Research council
Funder name
Biotechnology and Biological Sciences Research Council
Alternative name(s)
BBSRC
Funding Body Type
government organisation
Funding Body Subtype
National government
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
Basic results (scientific)
Publication list