Protocol summary

Summary
This double-blind controlled clinical trial will recruit 60 patients with verruca vulgaris -with minimum of one lesion that has minimum diameter of 6 millimeter- who visit the dermatology clinic of Afzalipour Hospital (kerman, Iran). Exclusion criteria are lesions on face, genitalia and periungual; patients under 12 and above 50 years; immune suppression; pregnancy and lactating; patients who has received any treatment. Table of random numbers will be used for random allocation of the patients. Both groups will receive cryotherapy with liquid nitrogen (with the usage of cotton swabs and double freez-thaw cycle until creating two-millimeter white halo around lesions) every other week . Patients in group A and B will receive 2% niosomal zinc sulfate cream and placebo twice a day, respectively. Treatment will be performed for maximum 3 months or until total clearance of the lesions, whichever occurs first. The patients will be included if diagnosis is confirmed by careful clinical examination. A demographic questionnaire and consent form will be filled out at baseline. A researcher unaware of grouping will visit at baseline and after 2, 4, 6, 8,10 and 12 weeks. Every other week patients in both groups will be visited by researcher to observe side effects (hyperpigmentation, hypopigmentation, blister, pruritus) and lesion's response to treatment (complete lesion disappearance, size reduction). Two and four weeks after clearance of lesions patients will be examined for any possible recurrence.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017100936660N1
Registration date: 2017-10-27, 1396/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-27, 1396/08/05
Registrant information
Name
Fahameh Fadaeiresketi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8328
Email address
f.fadaei@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of topical Niosomal Zinc Sulfate plus cryotherapy and placebo plus cryotherapy in the treatment of Verruca Vulgaris
Public title
Comparison between cryotherapy and topical zinc sulfate with cryotherapy and placebo in common wart treatment
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: consent to participate; verruca vulgaris patients with minimum of one lesion that has minimum diameter of 6 millimeter exclusion criteria: lesions on face, genitalia and periungual; patients under 12 and above 50 years; immune suppression; pregnancy and lactating; patients who has received any treatment
Age
From 12 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Table of random numbers (mini tab 16 software)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe of Kerman University of Medical Sciences
Street address
Pardis of Kerman University of Medical Sciences,beginning of Haftbagh Alavi Highway,Kerman
City
Kerman
Postal code
7616913555
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.KMU.REC.1394.226

Health conditions studied

1

Description of health condition studied
verruca vulgaris
ICD-10 code
B07
ICD-10 code description
viral warts

Primary outcomes

1

Description
size of lesion
Timepoint
before intervention, 2, 4, 6, 8, 10 and 12 weeks after intervention
Method of measurement
scaling with ruler( in millimeter)

2

Description
treatment sessions number
Timepoint
every other week until complete resolusion or up to 3 months
Method of measurement
counting

Secondary outcomes

1

Description
hyperpigmentation
Timepoint
2, 4, 6, 8, 10 and 12 weeks after intervention
Method of measurement
inspection

2

Description
hypopigmentation
Timepoint
2, 4, 6, 8, 10 and 12 weeks after intervention
Method of measurement
inspection

3

Description
blister
Timepoint
2, 4, 6, 8, 10 and 12 weeks after intervention
Method of measurement
inspection

4

Description
pain
Timepoint
2, 4, 6, 8, 10 and 12 weeks after intervention
Method of measurement
questionnaire

5

Description
pruritus
Timepoint
2, 4, 6, 8, 10 and 12 weeks after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
intervention: cryotherapy of lesions every other week plus application of topical niosomal zinc sulfate two times a day until complete remission or for maximum duration of 3 month
Category
Treatment - Drugs

2

Description
control: cryotherapy of lesions every other week plus application of placebo two times a day until complete remission or for maximum duration of 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology Clinic, Afzalipour Hospital
Full name of responsible person
Fahameh Fadaeiresketi
Street address
Afzalipour Hospital, Imam Khomeini Highway
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Ebne Sina St. ,Tahmasbabad Crossroad
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fahameh Fadaeiresketi
Position
resident
Other areas of specialty/work
Street address
Afzalipour Hospital, Imam Khomeini Highway
City
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Fax
+98 34 3325 7477
Email
f.fadaei@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Mahin Aflatoonian
Position
Dermatopathology Fellowship
Other areas of specialty/work
Street address
Afzalipour Hospital, Imam Khomeini Highway
City
Kerman
Postal code
Phone
+98 34 3325 7651
Fax
Email
maaflatoonian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fahameh Fadaeiresketi
Position
Resident
Other areas of specialty/work
Street address
Afzalipour Hospital, Imam Khomeini Highway
City
Kerman
Postal code
Phone
+98 34 3132 8328
Fax
Email
f.fadaei@kmu.ac.ir; fahameh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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