1. Determining the effect of cryotherapy treatment alone on the resolution of wart lesions in patients
2. Determining the effect of combined cryotherapy treatment with acyclovir injection on resolution of wart lesions in patients
3. Comparing the effect of cryotherapy with combined treatment of cryotherapy and acyclovir injection in patients
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 80 patients. Envelope method was used for randomization.
Settings and conduct
This double-blind clinical trial will be conducted on 80 patients referred to the Sinai Hospital in Tabriz in 1402. The first group will be treated with cryotherapy and placebo and the second group will be treated with combined cryotherapy treatment with intralesional injection of acyclovir for every two weeks and a maximum of 10 weeks (5 times). Photographs and clinical examinations will be taken before treatment and at each follow-up visit. Response to treatment and complications are also reviewed
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients with hand and foot warts resistant to three cryotherapy sessions, age over 12 years, people with less than 10 warts, and exclusion criteria include women during pregnancy and breastfeeding, use of treatment Anti-wart in the last 4 weeks, patients are treated with antiviral drugs such as acyclovir, cidofovir for other disorders.
Intervention groups
In cryotherapy group, liquid nitrogen and a cotton applicator will be used in the leg or hand lesion of the patient. Normal saline is also injected as a placebo.
In the group undergoing combined treatment of cryotherapy with acyclovir injection, first cryotherapy will be performed in the same way, then acyclovir will be injected in the amount of one tenth of cc in each lesion.
Main outcome variables
Treatment response; Complications of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002581N11
Registration date:2024-05-02, 1403/02/13
Registration timing:retrospective
Last update:2024-05-02, 1403/02/13
Update count:0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Hamide Herizchi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4650
Email address
herizchih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficet of cryotherapy with cryotherapy and Acyclovir injection in patients with hand and foot resistant wart
Public title
Comparison of the efficet of cryotherapy with cryotherapy and Acyclovir injection in patients with wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients (male and female) with hand and foot wart resistant to three sessions of cryotherapy
Age above 12 years
People with less than 10 warts
Exclusion criteria:
Women during pregnancy and breastfeeding
patients used anti-wart treatment in the last 4 weeks
patients treated with antiviral drugs such as acyclovir, cidofovir for other disorders
Age
From 12 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the treatment, the patients will be given two envelopes, in one of which cryotherapy and in the other cryotherapy with acyclovir injection are recorded on paper, and the patient will randomly choose one envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and professionals who administered the injections were blinded as to which treatment they received. Injections are performed at the same time and place by a dermatologist who is uninformed about the ingredients in the syringe. Assessors of clinical evaluations will also be unaware of treatment allocation and not involved during treatment. Photos will be evaluated by 2 dermatologists blindly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Approval date
2024-04-16, 1403/01/28
Ethics committee reference number
IR.TBZMED.REC.1403.009
Health conditions studied
1
Description of health condition studied
Resistant arm and leg wart
ICD-10 code
B07.0
ICD-10 code description
Plantar wart
Primary outcomes
1
Description
Response to treatment
Timepoint
once every two weeks
Method of measurement
History and clinical examination
2
Description
Side effects
Timepoint
once every two weeks
Method of measurement
History and clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ّFirst group: cryotherapy
Category
Treatment - Drugs
2
Description
Intervention group: the second group with combined cryotherapy treatment with intralesional injection of acyclovir
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and Treatment Center of Sina, Tabriz
Full name of responsible person
Dr Hamideh Herizchi Ghadim
Street address
Skin Hospital, Skin disease
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 3637 0947
Email
herizchih@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Herizchi Hamide
Street address
Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 3637 3944
Email
herizchih@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Herizchi
Position
Assistant Professor, Derrmatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 1336 4650
Fax
Email
herizchih@TBZMED.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Herizchi
Position
Assistant Professor, Derrmatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 1336 4650
Fax
Email
herizchih@TBZMED.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Herizchi
Position
Assistant Professor, Derrmatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Phone
+98 41 1336 4650
Fax
Email
herizchih@TBZMED.ac.ir
Web page address
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
No - There is not 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
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.