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ISRCTN
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ISRCTN04517596
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ClinicalTrials.gov identifier
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Public title
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A double-blind, placebo controlled, randomised study to assess the value of free radical scavengers in reducing inflammation induced by cryotherapy
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0593115224
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Study hypothesis
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The aims of the study are to investigate and quantify the response of:
1. Oedema and blister formation
2. Erythema
3. Pain induced by cryotherapy in patients receiving a combination of a high dose of systemic vitamins C and E prior to treatment in comparison to placebo group.
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Ethics approval
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Not provided at time of registration
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Study design
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Double-blind, placebo controlled, randomised study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Skin and Connective Tissue Diseases: Hand warts
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Participants - inclusion criteria
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100 randomised (1:1) patients aged 18 years and over referred to the dermatology clinic for cryotherapy of hand warts that have failed to respond to topical salicylic acid preparations will be asked after appropriate counselling to participate in the trial.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2002
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Anticipated end date
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31/12/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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100
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Interventions
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Double-blind, parallel group, randomised study of the effect of a high dose combined systemic vitamin C and E on inflammation-induced cryotherapy.
1. Enrolment - It is proposed to enrol 100 patients with hand warts. Each patient will be assigned a unique number. Subjects will be patients referred to the Dermatology Department for the treatment of hand warts. Subjects will be required to provide written informed consent.
2. Randomisation Treatment will be allocated by randomising patients into balanced blocks of four. The pharmaceutical company providing the drugs will be responsible for the process of randomisation.
3. Study drug administration - Patients with hyperkeratotic hand warts (size 4-8 mm) will receive either a combined preparation of vitamin C (2000 mg) and vitamin E (800 iu) daily or placebo for 7 days prior to cryotherapy to a hand wart.
4. Treatment with Cryotherapy - The wart will be treated with a single application of cryotherapy from CRY-AC spray to obtain a 1-mm halo around the wart and just sufficient to maintain this for further 10 s. The CRY-AC spray will be half full with liquid nitrogen and the nozzle will be kept approximately 1cm away from the treated lesion. Different size cardboard templates will be treated with liquid nitrogen. Patients will be seen and assessed 24 h after cryotherapy.
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Primary outcome measure(s)
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Change in wart volume assessed 24 h after cryotherapy for the grade of oedema.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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South Warwickshire General Hospitals NHS Trust (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15663493
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Contact name
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Dr
F
Humphreys
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Address
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Department of Dermatology
South Warwickshire General Hospitals NHS Trust
Warwick Hospital
Lakin Road
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City/town
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Warwick
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Zip/Postcode
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CV34 5BW
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Country
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United Kingdom
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Tel
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+44 (0)1926 495 321
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Fax
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+44 (0)1926 482 603
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Email
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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16/03/2009
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Date ISRCTN assigned
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12/09/2003
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