Condition category
Signs and Symptoms
Date applied
02/09/2010
Date assigned
21/09/2010
Last edited
21/09/2010
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

Prof Martin Church

ORCID ID

Contact details

Dermatopharmacology Unit
South Block 825
Southamptom General Hospital
Southampton
SO16 6YD
United Kingdom
mkc@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HHSOT.01

Study information

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

Acronym

Study hypothesis

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

Southampton and South West Hampshire Research Ethics Committee approved in March 2000 (ref: 00/100)

Study design

Randomised double-blind vehicle controlled intra-subject trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase I/II

Drug names

Sodium cromoglicate

Primary outcome measures

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 trial start date

01/04/2000

Overall trial end date

01/08/2000

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

16 to 20 subjects per part (three parts)

Participant 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

Recruitment start date

01/04/2000

Recruitment end date

01/08/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dermatopharmacology Unit
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Hewlett Healthcare Ltd (UK)

Sponsor details

No.1 Mill
The Wharf
Shardlow
Derby
DE72 2GH
United Kingdom
james@hewlett-healthcare.co.uk

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Hewlett Healthcare Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11159712
2. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15005740

Publication citations

  1. Results

    Ahluwalia P, McGill JI, Church MK, Nedocromil sodium inhibits histamine-induced itch and flare in human skin., Br. J. Pharmacol., 2001, 132, 3, 613-616, doi: 10.1038/sj.bjp.0703852.

  2. Results

    Willis EF, Clough GF, Church MK, Investigation into the mechanisms by which nedocromil sodium, frusemide and bumetanide inhibit the histamine-induced itch and flare response in human skin in vivo., Clin. Exp. Allergy, 2004, 34, 3, 450-455.

Additional files

Editorial Notes