Condition category
Skin and Connective Tissue Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/03/2009
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

Dr F Humphreys

ORCID ID

Contact details

Department of Dermatology
South Warwickshire General Hospitals NHS Trust
Warwick Hospital
Lakin Road
Warwick
CV34 5BW
United Kingdom
+44 (0)1926 495 321

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15663493

Publication citations

  1. 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.

Additional files

Editorial Notes