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Comparison of intralesional 5-fluorouracil and cryotherapy in the treatment of common and palmoplantar warts

Protocol summary

Study aim
Determination and comparison of the effuicacy of intralesional 5-fluorouracil and cryotherapy in the treatment of common and palmoplantar warts
Design
Phase 3, parallel group, clinical trial, with consecutive sampling, including 50 patients, single blinded, computerized randomized with permuted blocks
Settings and conduct
The study is conducted in the dermatology clinic of Shiraz University of Medical Sciences. Group 1 is treated by weekly intralesional 5-fluorouracil injection and group 2 by weekly cryotherapy. The patients are assessed at the beginning of treatment, and weeks 1, 2, 3, 4, 5, 6, 8, and 14 by lesion size calculation by ruler and dermatoscopy. The outcome assessor is blind to the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients of 16 years of age and higher; Common type warts; Palmoplantar type warts Exclusion criteria: Patients with more than 5 lesions; Pregnancy; Lactation; Patients with vascular, cardiovascular, hepatic, and chronic kidney disease; Patients with hypersensitivity to 5-flurouracil, lidocaine, epinephrine, or cryotherapy; Beta-blocker drug consumption; Immunocompromised patients
Intervention groups
Group 1: Intralesional 5-fluorouracil injection Group 2: Cryotherapy
Main outcome variables
Complete clinical cure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140212016557N6
Registration date: 2021-05-18, 1400/02/28
Registration timing: prospective

Last update: 2021-05-18, 1400/02/28
Update count: 0
Registration date
2021-05-18, 1400/02/28
Registrant information
Name
Mozhdeh Sepaskhah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 712125239
Email address
sepaskhah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-28, 1400/03/07
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intralesional 5-fluorouracil and cryotherapy in the treatment of common and palmoplantar warts
Public title
Comparison of efficacy of intralesional 5-fluorouracil and cryotherapy in the treatment of common and palmoplantar warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of 16 years of age and higher Common type warts Palmoplantar type warts
Exclusion criteria:
Patients with more than 5 lesions Pregnancy Lactation Patients with vascular, cardiovascular, hepatic, and chronic kidney disease Patients with hypersensitivity to 5-flurouracil, lidocaine, epinephrine, or cryotherapy Beta-blocker drug consumption Immunocompromised patients
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomized using permuted block randomization (size of each block: 4), in individual units, using random allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the different treatment methods, the participants cannot be blinded. Principle investigator, and care provider physician are also aware of the type pf drugs. But, outcome assessors are not aware of the treatment of each patient.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz. Iran
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
IR.SUMS.MED.REC.1399.594

Health conditions studied

1

Description of health condition studied
palmoplantar wart
ICD-10 code
B07.0
ICD-10 code description
Plantar wart

2

Description of health condition studied
Common wart
ICD-10 code
B07.8
ICD-10 code description
Other viral warts

Primary outcomes

1

Description
Complete clinical cure
Timepoint
At the beginning of treatment, and weeks 1, 2, 3, 4, 5, 6, 8, and 14
Method of measurement
Lesion size calculation by ruler and dermatoscopy

Secondary outcomes

1

Description
Pain during treatment
Timepoint
Weeks 1, 2, 3, 4, 5, 6
Method of measurement
Pain illustrated numerical rating scale

2

Description
Quality of life
Timepoint
At the beginning of treatment, and the end of treatment
Method of measurement
Dermatology quality of life index Persian version

Intervention groups

1

Description
Intervention group: Intralesional 5-fluorouracil injection, once weekly, for 6 weeks
Category
Treatment - Drugs

2

Description
Control group: Cryotherapy, once weekly, for 6 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic, Shahid Faghihi hospital
Full name of responsible person
Mozhdeh Sepaskhah
Street address
Dermatology clinic, Faghihi hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5239
Email
sepaskhah@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaian zade
Street address
Research Council, Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Research grant of the Research Council of Shiraz University of Medical Sciences
Grant code / Reference number
20139
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mina Bazyar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic, Faghihi hospital, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3231 9049
Fax
+98 71 3231 9049
Email
minabazyar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 712125239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 712125239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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