Protocol summary
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Study aim
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The effect of calcitriol ointment on the treatment of skin warts
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Design
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Two arm parallel-group randomised trial with blinded postoperative care and outcome assessment
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Settings and conduct
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This study is a randomized controlled clinical trial and all patients with cutaneous warts referred to dermatology clinic of Bu Ali Sina Hospital in Sari during the years 98 to 99 with inclusion criteria and excluding exclusion criteria were included. Individuals' personal information including age, sex, number of lesions, duration of the lesion is recorded in the questionnaire by the designers.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Patients with cutaneous warts that are diagnosed by a dermatologist clinically or pathologically and need treatment.
- Over 4 years old
- Informed consent to enter the study
-The number of warts up to 20
Exclusion criteria:
- Children under 2 years, pregnant and lactating women
- Patients who are contraindicated for calcipotriol treatment.
- Facial genital warts
- Patients who do not consent to participate in the study.
- People who are allergic to topical vitamin D derivatives.
-Widespread warts that need further treatment.
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Intervention groups
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Intervention group: 0.005% calcitriol ointment in addition to the routine treatment twice daily (every 12 hours) is applied by the patient or his / her parents on the lesions so that the ointment with a thickness of one millimetre is applied on the lesion surface.
Control group: Only receive routine treatment.
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Main outcome variables
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Response to treatment is considered complete response, partial improvement (reduction in the number and in individual lesions size reduction) as of measurement and expression of percentage and no improvement, and 4 months after complete recovery of the patient, recurrence of lesions is examined.
General information
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Reason for update
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typographical mistakes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170818035762N2
Registration date:
2020-02-17, 1398/11/28
Registration timing:
registered_while_recruiting
Last update:
2020-09-30, 1399/07/09
Update count:
1
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Registration date
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2020-02-17, 1398/11/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-21, 1398/11/01
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Expected recruitment end date
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2020-03-20, 1399/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of calcipotriol ointment in the treatment of cutaneous wart
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Public title
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The effect of calcitriol ointment on skin warts
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with cutaneous warts that are clinically or pathologically diagnosed by a dermatologist and need treatment
The number of warts up to 20
Minimum enrollment age is 4 years
Exclusion criteria:
People who are allergic to topical vitamin D derivatives.
Warts that need further treatment.
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Age
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From 4 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First, according to the inclusion criteria, 56 patient will be selected by the available sampling method. Then, this 56 patient will be assigned to 2intervention and control groups. The blocking process will be done with the Rando allocation software. This software will create 14 blocks containing 4 patient and the samples will be grouped accordingly.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Blinding in this study will be done like this the intervention group will receive routine treatment in addition to calcitriol ointment and the control group will receive only routine treatment. The researcher, patient, and individual analyzer will not be aware of the type of medication prescribed by the physician.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-01-05, 1398/10/15
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Ethics committee reference number
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IR.MAZUMS.REC.1398.1259
Health conditions studied
1
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Description of health condition studied
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Skin warts
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ICD-10 code
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B07
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ICD-10 code description
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Viral warts
Primary outcomes
1
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Description
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Response to treatment is considered complete response, relative improvement (reduction in number and size reduction in individual lesions) as measurement and expression of percentage and no improvement.
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Timepoint
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The patient is examined monthly by a dermatologist
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Method of measurement
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Based on clinical examination of dermatologist
Intervention groups
1
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Description
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Intervention group: 0.005% calcipotriol ointment in addition to the routine treatment twice daily (every 12 hours) is applied by the patient or his / her parents on the lesions, so that the ointment with a thickness of one millimeter is applied on the lesion surface. . The patient is visited by a physician on a monthly basis the number and size of lesions, complications such as erythema and scaling around the lesion, pain, worsening of the lesions, and other associated symptoms. Treatment is continued for 2 months and if not treated for up to 4 months.
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Category
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Treatment - Drugs
2
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Description
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Control group: This group will only receive routine treatment
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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No
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Only part of the data, such as information about the main outcome or the like, can be shared
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When the data will become available and for how long
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Start of access period 6 months after stablishing results
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To whom data/document is available
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It will only be available to researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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It will only be available to researchers working in academic and scientific institutions
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From where data/document is obtainable
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Email to: A.kazeminejad@mazums.ac.ir
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What processes are involved for a request to access data/document
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After communicating with the email if available, data and results will be available
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Comments
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