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Comparisom of Liquid Nitrogen and Vitamin D3 in The Treatment of Cutaneous Warts

Sponsor
Combined Military Hospital Abbottabad (Other)
Overall Status
Completed
CT.gov ID
NCT05739786
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
9.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: liq nitrogen
  • Drug: intralesional vitamin D3
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Comparison of Efficacy of Liquid Nitrogen Versus Vitamin D3 in The Treatment of Cutaneous Warts
Actual Study Start Date :
May 11, 2022
Actual Primary Completion Date :
Nov 11, 2022
Actual Study Completion Date :
Nov 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A liquid nitrogen

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.

Drug: liq 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.
Other Names:
  • cryotherapy

    		•
    Active Comparator: Group B intralesional Vit D3

    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.

    Drug: intralesional vitamin 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.

    Outcome Measures

    Primary Outcome Measures

    1. Effectiveness of liquid nitrogen and intralesional vitamin D3 in treatment of cutaneous warts [9 weeks]

      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"

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sara Ilyas Abbottābād Kpk Pakistan 22010

    Sponsors and Collaborators

    • Combined Military Hospital Abbottabad

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Ilyas, principal investigator, Combined Military Hospital Abbottabad
    ClinicalTrials.gov Identifier:
    NCT05739786
    Other Study ID Numbers:
    • CMHAtd-ETH-17-DERM-22
    First Posted:
    Feb 22, 2023
    Last Update Posted:
    Feb 22, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Warts
    Vitamin D
    Cholecalciferol

    Study Results

    No Results Posted as of Feb 22, 2023