Assessment of the effects of topical sodium cromoglicate on itch and flare in human skin
| ISRCTN | ISRCTN35671014 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35671014 |
| Secondary identifying numbers | HHSOT.01 |
- Submission date
- 02/09/2010
- Registration date
- 21/09/2010
- Last edited
- 21/09/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Martin Church
Scientific
Scientific
Dermatopharmacology Unit
South Block 825
Southamptom General Hospital
Southampton
SO16 6YD
United Kingdom
| mkc@soton.ac.uk |
Study information
| Study design | Randomised double-blind vehicle controlled intra-subject trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | To assess the effects of topical sodium cromoglicate on itch and flare in human skin induced by intradermal histamine: a randomised double-blind vehicle controlled intra-subject design trial |
| Study objectives | The intradermal injection of histamine in human skin results in a weal, flare and increased blood flux accompanied by severe itching. We have previously shown that the chromone, nedocromil sodium when introduced into the skin using iontophoresis can reduce the severity of the itch and the size of the flare, but with no effect on the weal or blood flux. We hypothesise that the related chromone, sodium cromoglicate will have the same effect both when introduced by iontophoresis and when applied topically to the skin using a new cutaneous emulsion, Altoderm. |
| Ethics approval(s) | Southampton and South West Hampshire Research Ethics Committee approved in March 2000 (ref: 00/100) |
| Health condition(s) or problem(s) studied | Itch and flare in human skin |
| Intervention | 1. 4% sodium cromoglicate dissolved in reversed osmosis purified water or reversed osmosis purified water, delivered by iontophoresis to skin. Total duration of treatment: single treatment only Total duration of follow-up: one hour after study completion 2. 4% sodium cromoglicate cutaneous emulsion or vehicle, applied topically to skin Total duration of treatment: three days of treatment before study day Total duration of follow-up: one hour after last treatment 3. 1%, 2% 4% sodium cromoglicate cutaneous emulsion or vehicle, applied topically to skin Total duration of treatment: three days of treatment before study day Total duration of follow-up: one hour after last treatment All subjects challenged with intrademal histamine, 20 microlitres of 1 micromolar. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | Sodium cromoglicate |
| Primary outcome measure | 1. Change in severity of itch measured every 20 seconds for 5 minutes after injection of histamine using 100 mm Visual Analogue Scale 2. Change in area of flare and blood flux using scanning laser Doppler imaging 3. Change in area of weal using planimetry |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/04/2000 |
| Completion date | 01/08/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 16 to 20 subjects per part (three parts) |
| Key inclusion criteria | 1. Healthy adult volunteers (18 - 65 years old), male only 2. Recruited from the staff and students of Southampton University Medical School and Southampton General Hospital |
| Key exclusion criteria | 1. Pregnancy 2. Presence of skin disease 3. Taking of drugs which may interfere with the study, including corticosteroids, antihistamines, antidepressants and psychotropic drugs |
| Date of first enrolment | 01/04/2000 |
| Date of final enrolment | 01/08/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dermatopharmacology Unit
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Hewlett Healthcare Ltd (UK)
Industry
Industry
No.1 Mill, The Wharf
Shardlow
Derby
DE72 2GH
United Kingdom
| james@hewlett-healthcare.co.uk |
Funders
Funder type
Industry
Hewlett Healthcare Ltd (UK)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2001 | Yes | No | |
| Results article | results | 01/03/2004 | Yes | No |
