The study aims to assess the impact of vitamin D ointment on anogenital wart lesions as a new therapeutic method and compare it with common treatment (cryotherapy). Due to the lack of reported side effects, we will also report the resulting side effects.
Design
A single-blinded, randomized trial with two parallel arms that will be performed with 30 patients in each arm. Random allocation software was used to assign patients randomly.
Settings and conduct
The study is conducted in Razi Hospital, located in Tehran. Referred patients are first examined, and will be included in the study if they are eligible. The included patients are unaware of the therapy (vitamin D ointment or vaseline). Both medications are given in the same containers to perform proper blinding.
Participants/Inclusion and exclusion criteria
Age over 18, more than 2 warts in anogenital area, willingness to participate, absence of inflammatory skin disease and rheumatological disease, absence of liver and kidney disease, absence of allergy to vitamin D, absence of malignancy, diabetes and immunodeficiency, absence of pregnancy and breastfeeding
Intervention groups
There are two intervention groups in this study. The first group will receive cryotherapy plus vitamin D ointment and the second group will receive cryotherapy plus placebo (vaseline). Cryotherapy sessions will be performed at three-week intervals, and the patients of both groups will utilize the topical treatment twice a day. The study duration is three months.
Main outcome variables
Measuring the number and size of genital warts
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230124057201N4
Registration date:2023-11-25, 1402/09/04
Registration timing:prospective
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Zeinab aryanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 0853
Email address
z_aryanian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of topical vitamin D3 and cryotherapy in comparison with cryotherapy in treating anogenital warts
Public title
Investigating the impact of topical vitamin D on anogenital warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of HPV
Patients with more than two genital warts in genitalia (perinea, groin, anus)
Age more than 18
Willingness to participate in the study
Exclusion criteria:
Inflammatory skin disease
Rheumatological disease
Malignancy
Kidney and liver disease
Eczema
Diabetes mellitus
Previous history of allergy to vitamin D
Acquired immunodeficiency
Pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to cryotherapy and placebo or cryotherapy and drug via block randomization with blocks of four. Random allocation software was used to make a list of random numbers. If the number made by software was between 0 and 4, the patients belonged to the placebo group, and if the number was between 5 and 9, the patients were placed in the drug group. The process was repeated until all the eligible patients were included in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients enrolled in the study are not aware of the received medicine (placebo or vitamin D ointment) that is given with cryotherapy. To avoid identifying the type of drug, placebo (vaseline) and drug (vitamin D ointment) are given in the same containers previously prepared.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of tehtan university of medical science
Street address
Tehran University of medical sience, ghods street,keshavarz boulevard
City
Tehtan
Province
Tehran
Postal code
1417613151
Approval date
2023-11-12, 1402/08/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.436
Health conditions studied
1
Description of health condition studied
genital warts
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts
Primary outcomes
1
Description
Measuring size and number of anogenital warts
Timepoint
Baseline visit, then every three week up to four sessions
Method of measurement
Lesion count, surgical grading ruler
Secondary outcomes
1
Description
Qualitative evaluation of response to treatment (complete response, partial response 50-99%, no response less than 50%)
Intervention group: Patients in addition to four cryotherapy sessions will use vitamin D ointment (calciderm) twice a day. the interventions will continue for three months.
Category
Treatment - Drugs
2
Description
Control group: In this group, in addition to four cryotherapy sessions, patients will use a placebo (Vaseline) twice a day. the intervention will also be three months in this group.