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Assessment of the effects of topical sodium cromoglicate on itch and flare in human skin

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35671014
Enrollment
60
Registered
2010-09-21
Start date
2000-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Itch and flare in human skin Signs and Symptoms Itch and flare

Interventions

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

Sponsors

Hewlett Healthcare Ltd (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026