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Trial registered on ANZCTR


Registration number
ACTRN12610000679088
Ethics application status
Approved
Date submitted
16/08/2010
Date registered
18/08/2010
Date last updated
18/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot, parallel-group, randomised controlled trial on the effectiveness of 10% Formalin in the treatment of plantar warts.
Scientific title
A randomised controlled pilot study on the effectiveness of 10% Formalin in the treatment of plantar warts.
Secondary ID [1] 252428 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
plantar verrucae (viral warts on the feet) 257936 0
Condition category
Condition code
Skin 258107 258107 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve an initial appointment where the participant will be randomised to either of the treatments (10% formalin or the placebo) and screened for eligibility. The participants will then have the area of their plantar wart debrided (this is where the dead skin overlying the wart will be scraped away) the primary investigator will apply the 10% Formalin treatment solution topically over the wart using a cotton bud, which has been dipped into the solution (this will occur at monthly appointments to a maximum of six months).The participant will then be given instructions (both written and verbal) where they will sand the wart area with 120 grit sand paper and topically apply the 10% Formalin treating solution to the wart. The participant will do this every night for a month (maximum treatment period of 6 months). At any of the monthly appointments if the participant is deemed to no longer have the plantar wart i.e. it has been cured, the participant will cease to use the treatment and they will attend a final follow-up appoinment where they will be clinically examined to assess reoccurance of the plantar wart. The initial appoinment is estimated to take between 30-45 minutes. Thereafter the monthly appoinments are estimated to take between 15-30 minutes and the final follow-up appointment would take about 15 minutes.
Intervention code [1] 256994 0
Treatment: Other
Intervention code [2] 257036 0
Treatment: Drugs
Comparator / control treatment
The intervention will involve an initial appointment where the participant will be randomised to either of the treatments (10% formalin or the placebo- water with vanilla essence added) and screened for eligibility. The participants will then have the area of their plantar wart debrided (this is where the dead skin overlying the wart will be scraped away) the primary investigator will apply the placebo treatment solution topically over the wart using cotton bud, which has been dipped into the solution (this will occur at monthly appointments to a maximum of six months).The participant will then be given instructions (both written and verbal) where they will sand the wart area with 120 grit sand paper and topically apply the placebo treating solution to the wart. The participant will do this every night for a month (maximum treatment period of 6 months). At any of the monthly appointments if the participant is deemed to no longer have the plantar wart i.e. it has been cured, the participant will cease to use the treatment and they will attend a final follow-up appoinment where they will be clinically examined to assess reoccurance of the plantar wart. The initial appoinment is estimated to take between 30-45 minutes. Thereafter the monthly appoinments are estimated to take between 15-30 minutes and the final follow-up appointment would take about 15 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 258969 0
effectiveness- plantar warts presence or eradication measured via clinical examination this is where two independent podiatrists will examine the plantar wart and determine whether it is present or eradicated using the following criteria: present- interruption to skin lines, presence of central core with punctuate haemorrhages, on the plantar surface of the foot. Eradicated- return of skin lines and no central core with punctuate haemorrhages. Other measurment tools will be pre and post photographs of the wart, with a fixed focus camera.
Timepoint [1] 258969 0
this will be done at monthly appointments, with a maximum time period of 6 months. Monnthly appointments starting at enrolment.
Primary outcome [2] 258970 0
Reoccurance of the plantar wart post treatment, measured via clinical examination using the following criteria: present- interruption to skin lines, presence of central core with punctuate haemorrhages, on the plantar surface of the foot. Eradicated- return of skin lines and no central core with punctuate haemorrhages and pre and post photographs of the plantar wart.
Timepoint [2] 258970 0
4 week follow-up appointment (post treatment)
Secondary outcome [1] 265155 0
Pain, measured with the visual analogue scale for participants 12 years and up, and the Faces Pain scale- revised for participants between 4-11 years of age.
Timepoint [1] 265155 0
measured with the primary investigator at monthly appointments for a maximum of six months and every night in a diary after application of treatment at home for a maximum of six months. The monthly appoinments begin at enrolment.
Secondary outcome [2] 265156 0
The time taken (measured in months) for the patients to recover from the plantar warts.
Timepoint [2] 265156 0
Every month for a maximum of six months starting at enrolment.

Eligibility
Key inclusion criteria
plantar wart present on at least one foot, multiple warts will be treated as one person not one wart, willingness to participate in the study, ability to communicate in english
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
sensitivity to formalin, younger than four years of age, immunocompromised, vascular or neurologically compromised in feet

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants will be recruited via an email through University of South Australia, advertisement in The Athletes stores (City, Modbury and Elizabeth) Also an advertisement through the Messenger Press. Any participants that enquire through the Podiatry clinic via telephone will be sent an information sheet etc. They will then be randomly assigned to either of the treatment groups where they will be assessed, via 2 independent clinicians and a podiatry student, who are unaware to which treatment group the participant has been assigned to. The clinicians and the podiatry student and participants will be blinded to which treatment group contains the particular treatment. Allocation will happen as follows: the randomisation list will be generated by an independent person where the participant will receive a numbered container that could have either the 10% formalin in or the placebo. The containers will all be in same sized, brown bottles with just numbered labels.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be done via random number generation through microsoft excel by an independent person. This will be done before the participants to ensure that they are randomly assigned to one of the two treatment groups. The two treatment groups will be allocated and assigned either treatment A or B and will remain coded until the discussion and conclusion are required to be written.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257472 0
University
Name [1] 257472 0
University of South Australia
Country [1] 257472 0
Australia
Primary sponsor type
Individual
Name
Rolf Scharfbillig
Address
University of South Australia, School of Health Sciences, North Terrace, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 256699 0
Individual
Name [1] 256699 0
Kerwin Talbot
Address [1] 256699 0
University of South Australia, School of Health Sciences, North Terrace, Adelaide, South Australia, 5000
Country [1] 256699 0
Australia
Other collaborator category [1] 251445 0
Individual
Name [1] 251445 0
Sara Jones
Address [1] 251445 0
University Of South Australia, School of Health Sciences, North Terrace, Adelaide, South Australia, 5000
Country [1] 251445 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259497 0
University of South Australia, Human Research Ethics Committee
Ethics committee address [1] 259497 0
GPO Box 2471 Adelaide, South Australia, 5001
Ethics committee country [1] 259497 0
Australia
Date submitted for ethics approval [1] 259497 0
12/07/2010
Approval date [1] 259497 0
10/08/2010
Ethics approval number [1] 259497 0
0000021071

Summary
Brief summary
The primary purpose of this study is to investigate how effective 10% Formalin is as a topical treatment for eradicating plantar warts. Our hypothesis is that 10% formalin will be more effective in curing plantar warts then the control over a maximum of 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31510 0
Address 31510 0
Country 31510 0
Phone 31510 0
Fax 31510 0
Email 31510 0
Contact person for public queries
Name 14757 0
Dr. Rolf Scharfbillig
Address 14757 0
Univeristy of South Australia, School of Health Sciences, North Tce, Adelaide, South Australia, 5000
Country 14757 0
Australia
Phone 14757 0
+61 8 83022269
Fax 14757 0
+61 8 83022766
Email 14757 0
[email protected]
Contact person for scientific queries
Name 5685 0
Miss Kerwin Talbot
Address 5685 0
University of South Australia, School of Health Sciences, North Tce, Adelaide, South Austrlia, 5000
Country 5685 0
Australia
Phone 5685 0
+61 8 83022269
Fax 5685 0
+61 8 83022766
Email 5685 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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