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

NCT05739786 | Completed Phase 1

• 1 other identifier: CMHAtd-ETH-17-DERM-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Warts

Outcome Measures

Primary Outcomes (1)

• 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"

  9 weeks

Study Arms (2)

Group A liquid nitrogen

ACTIVE COMPARATOR

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

Group B intralesional Vit D3

ACTIVE COMPARATOR

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

Interventions

liq nitrogen DRUG

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.

Also known as: cryotherapy

Group A liquid nitrogen

intralesional vitamin D3 DRUG

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.

Group B intralesional Vit D3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient of cutaneous warts presented in dermatology department.

You may not qualify if:

• Immunosuppressed patients
• chronic skin diseases like eczema or autoimmune disease
• diabetes mellitus
• cold sensitivity , skin allergies
• pregnancy, and lactation
• periungual warts

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

Sara Ilyas

Abbottābād, Kpk, 22010, Pakistan

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 22, 2023
• Study Start: May 11, 2022
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

PA (1)