Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0593115224
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Double-blind, placebo controlled, randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Skin and Connective Tissue Diseases: Hand warts
Intervention
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.
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamin C, vitamin E
Primary outcome measure
Change in wart volume assessed 24 h after cryotherapy for the grade of oedema.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Dermatology
Warwick
CV34 5BW
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Warwickshire General Hospitals NHS Trust (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
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15663493
Publication citations
-
Results
Gach JE, Humphreys F, Berth-Jones J, Randomized, double-blind, placebo-controlled pilot study to assess the value of free radical scavengers in reducing inflammation induced by cryotherapy., Clin. Exp. Dermatol., 2005, 30, 1, 14-16, doi: 10.1111/j.1365-2230.2004.01694.x.