Back to resultsComparisom of Liquid Nitrogen and Vitamin D3 in The Treatment of Cutaneous Warts
Primary Purpose
Cutaneous Warts
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
liq nitrogen
intralesional vitamin D3
Sponsored by
About this trial
This is an interventional other trial for Cutaneous Warts
Eligibility Criteria
Inclusion Criteria: Patient of cutaneous warts presented in dermatology department. Exclusion Criteria: Immunosuppressed patients chronic skin diseases like eczema or autoimmune disease diabetes mellitus cold sensitivity , skin allergies pregnancy, and lactation periungual warts
Sites / Locations
- Sara Ilyas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A liquid nitrogen
Group B intralesional Vit D3
Arm Description
liquid nitrogen In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) for 3 sessions at every 3 weeks interval. Effectiveness in was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
intralesional Vit D3 Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
Outcomes
Primary Outcome Measures
Effectiveness of liquid nitrogen and intralesional vitamin D3 in treatment of cutaneous warts
For 2nd Article: A total of 60 female patients (30 patients in each group) with cutaneous warts diagnosed by a consultant dermatologist on physical examination were included in this study.
In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.Total duration of therapy for each patient will be 9 weeks after "recurrence and remission"
Secondary Outcome Measures
Full Information
NCT ID
NCT05739786
First Posted
January 18, 2023
Last Updated
February 13, 2023
Sponsor
Combined Military Hospital Abbottabad
1. Study Identification
Unique Protocol Identification Number
NCT05739786
Brief Title
Comparisom of Liquid Nitrogen and Vitamin D3 in The Treatment of Cutaneous Warts
Official Title
Comparison of Efficacy of Liquid Nitrogen Versus Vitamin D3 in The Treatment of Cutaneous Warts
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A total of 60 female patients (30 patients in each group) with cutaneious warts diagnosed by a consultant dermatologist on physical examination were included in this study.
In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Warts
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A liquid nitrogen
Arm Type
Active Comparator
Arm Description
liquid nitrogen In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) for 3 sessions at every 3 weeks interval. Effectiveness in was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
Arm Title
Group B intralesional Vit D3
Arm Type
Active Comparator
Arm Description
intralesional Vit D3 Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
Intervention Type
Drug
Intervention Name(s)
liq nitrogen
Other Intervention Name(s)
cryotherapy
Intervention Description
In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) for 3 sessions at every 3 weeks interval. Effectiveness in was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
Intervention Type
Drug
Intervention Name(s)
intralesional vitamin D3
Intervention Description
Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
Primary Outcome Measure Information:
Title
Effectiveness of liquid nitrogen and intralesional vitamin D3 in treatment of cutaneous warts
Description
For 2nd Article: A total of 60 female patients (30 patients in each group) with cutaneous warts diagnosed by a consultant dermatologist on physical examination were included in this study.
In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.Total duration of therapy for each patient will be 9 weeks after "recurrence and remission"
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient of cutaneous warts presented in dermatology department.
Exclusion Criteria:
Immunosuppressed patients
chronic skin diseases like eczema or autoimmune disease
diabetes mellitus
cold sensitivity , skin allergies
pregnancy, and lactation
periungual warts
Facility Information:
Facility Name
Sara Ilyas
City
Abbottābād
State/Province
Kpk
ZIP/Postal Code
22010
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Comparisom of Liquid Nitrogen and Vitamin D3 in The Treatment of Cutaneous Warts
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