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 |
| Protocol serial number | 7064 |
| Sponsor | Biotechnology and Biological Science Research Council (BBSRC) (UK) |
| Funder | Biotechnology and Biological Sciences Research Council |
- 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
Scientific
Dermatological Sciences
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom
| neil.gibbs@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Filaggrin |
| Primary outcome measure(s) |
Each week volunteers will be asked to complete a short questionnaire (POEM) |
| Key secondary outcome measure(s) |
1. General skin condition using a well established scoring system for AD (SCORAD) |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
The University of Manchester
Manchester
M13 9PT
United Kingdom
M13 9PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/09/2016: No publications found, verifying study status with principal investigator.
