A double-blind, placebo controlled, randomised study to assess the value of free radical scavengers in reducing inflammation induced by cryotherapy
| ISRCTN | ISRCTN04517596 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04517596 |
| Secondary identifying numbers | N0593115224 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F Humphreys
Scientific
Scientific
Department of Dermatology
South Warwickshire General Hospitals NHS Trust
Warwick Hospital
Lakin Road
Warwick
CV34 5BW
United Kingdom
| Phone | +44 (0)1926 495 321 |
|---|
Study information
| Study design | Double-blind, placebo controlled, randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2002 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Dermatology
Warwick
CV34 5BW
United Kingdom
CV34 5BW
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
South Warwickshire General Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2005 | Yes | No |
