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 |
| Protocol serial number | N0593115224 |
| Sponsor | Department of Health (UK) |
| Funder | South Warwickshire General Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind, placebo controlled, randomised study |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Change in wart volume assessed 24 h after cryotherapy for the grade of oedema. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Dermatology
Warwick
CV34 5BW
United Kingdom
CV34 5BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
