Comparison Between Topical Niosomal Zinc Sulfate Combined With Cryotherapy Versus topical simple Zinc sulfate Combined With Cryotherapy In The Treatment Of Verruca Vulgaris
Comparison Between Topical Niosomal Zinc Sulfate Combined With Cryotherapy Versus topical simple Zinc sulfate Combined With Cryotherapy In The Treatment of Verruca Vulgaris
Design
This study is a double-blind ,randomized clinical trial with control group and parallel group design
Settings and conduct
This is a double-blind randomized clinical trial study. 60 patients with common warts greater than 6 mm from both sexes over 12 years of old,attending Afzalipour Hospital in Kerman enrolled the study. Patients were allocated to 2 groups (intervention and control). Intervention group will receive cryotherapy with niosomal zinc sulfate solution and the control group will receive cryotherapy with simple zinc sulfate solution.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients older than 12 years old. Exclusion criteria: patients younger than 12 years old; immunocompromised patients, and those who have previously received treatment for warts. Pregnant or lactating women have facial, genital, and nail warts.
Intervention groups
Patients in case group were received cryotherapy with niosomal zinc sulphate solution (twice daily) and in control group received cryotherapy with simple zinc sulfate solution (twice daily).
Main outcome variables
Measurement of lesions؛ severity of warts
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190809044483N1
Registration date:2019-09-11, 1398/06/20
Registration timing:prospective
Last update:2019-09-11, 1398/06/20
Update count:0
Registration date
2019-09-11, 1398/06/20
Registrant information
Name
Roozbeh Mehrabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3261 5720
Email address
r.mehrabadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-02, 1398/07/10
Expected recruitment end date
2019-12-31, 1398/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Between Topical Niosomal Zinc Sulfate Combined With Cryotherapy Versus topical simple Zinc sulfate Combined With Cryotherapy In The Treatment Of Verruca Vulgaris
Public title
The effect of zinc sulfate in the treatment of common warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with common warts
Exclusion criteria:
Patients under 12 years
Patients with immunodeficiency
Patients who have already received treatment for warts
Pregnancy
Breastfeeding
Facial warts
Genital warts
Warts around the nail
Age
From 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was done using Minitab 16 software (Minitab Inc.)
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a triple-blind study for outcome assessor,patients and analyzor. Both drugs were kept in identical amber glass containers, so the evaluating physician and patients were unaware of the containers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Ebne Sina Ave.,Tahmasb Abad Blvd.
City
kerman
Province
Kerman
Postal code
761614111
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.KMU.AH.REC.1397.135
Health conditions studied
1
Description of health condition studied
Common wart
ICD-10 code
B07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
Measurement of wart lesion size
Timepoint
At base line and 2,4,6,8,12 weeks later
Method of measurement
Measurement of lesion size by physical examination
Secondary outcomes
1
Description
Hyperpimentation
Timepoint
At baseline (before intervention)and weeks 2,4,6,8,12
Method of measurement
By physical examination
2
Description
Hypopigmentation
Timepoint
At baseline (before intervention)and weeks 2, 4, 6, 8,12
Method of measurement
By physical examination
3
Description
Atrophic scar
Timepoint
At baseline (before intervention)and weeks 2, 4, 6, 8, 12
Method of measurement
By physical examination
Intervention groups
1
Description
Intervention group: niosomal Zinc sulfate solution, Route of administration : Topical application, twice daily, Duration of treatment: 12 weeks, Manufactured factory: Sorbital esters (Span compounds) and polyoxyethylene derivatives of sorbital esters (Tween compounds),The concentration of zinc sulfate used in the formulation was 2%. Chemicals and soluble materials were prepared by Merck Elemental and Sigma America and carl-roth Elemental, and is imported by Shafa.
Category
Treatment - Drugs
2
Description
Control group: Simple Zinc Sulfate Solution, Route of administration : Topical application, twice daily, Duration of treatment: 12 weeks, Preparation of topical simple zinc sulfate: Zinc sulfate dissolving in hot distilled water (90 ° C) 4% at base of eucerin.As such, after diluting at the base of eucerin, the final concentration of sulfate will be 2% by volumetric weight.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Mahin Aflatoonian
Street address
Imam high way,Kerman
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
maaflatoonian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Ebne sina Avenue,Jehad Blvd
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3855 3226
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahin Aflatoonian
Position
Assistant professor of dermatology
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour Hospital ,Imam Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
maaflatoonian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
مهین افلاطونیان
Position
Assistant professor of dermatology
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour Hospital,Imam Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8323
Email
maaflatoonian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahin Aflatoonian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour Hospital,Imam Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
maaflatoonian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the data can be shared after unidentifiable people.
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any analysis of the data is allowed but not published.A written request with a valid letter from a university or scientific institution with an identification card is required.
From where data/document is obtainable
Roozbeh Mehrabadi
What processes are involved for a request to access data/document
A written request will be submitted to the research Vice-chancellor of the Kerman University of Medical Sciences with a valid letter from the University or institute.