search
Back to results

Effect of Laser in Treatment of Vulval Warts

Primary Purpose

Vulval Wart

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
nd yag laser
Sponsored by
Aljazeera Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulval Wart

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • women who have vulval warts
  • Age between 18- 40 years

Exclusion Criteria:

  • warts that were previously treated by surgery or cryotherapy

Sites / Locations

  • Algazeerah and Kasralainy hospital
  • AlgazeerahRecruiting
  • Aljazeera( Al Gazeera) hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

nd yag laser

Co2 laser

Arm Description

Applying nd yag laser to vulva

Applying CO2 laser to vulva

Outcomes

Primary Outcome Measures

The number of women who will be completely cured by laser beam
how laser will cure the warts

Secondary Outcome Measures

Full Information

First Posted
February 2, 2019
Last Updated
August 4, 2019
Sponsor
Aljazeera Hospital
Collaborators
National Research Centre, Egypt
search

1. Study Identification

Unique Protocol Identification Number
NCT03830047
Brief Title
Effect of Laser in Treatment of Vulval Warts
Official Title
Effect of nd Yag Laser in Treatment of Vulval Warts
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
October 15, 2019 (Anticipated)
Study Completion Date
November 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
Collaborators
National Research Centre, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Vulval warts is a magor problem that affects women .
Detailed Description
The causative organism for vulval warts is human papilloma virus There are many treatment modalities that can trat these warts

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulval Wart

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
applying laser for treatment of vulval warts
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nd yag laser
Arm Type
Active Comparator
Arm Description
Applying nd yag laser to vulva
Arm Title
Co2 laser
Arm Type
Sham Comparator
Arm Description
Applying CO2 laser to vulva
Intervention Type
Device
Intervention Name(s)
nd yag laser
Other Intervention Name(s)
laser beam
Intervention Description
nd yag laser will be applied on the vulval warts
Primary Outcome Measure Information:
Title
The number of women who will be completely cured by laser beam
Description
how laser will cure the warts
Time Frame
within 2 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females who have vulval warts
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women who have vulval warts Age between 18- 40 years Exclusion Criteria: warts that were previously treated by surgery or cryotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Alalfy, PhD
Phone
01002611058
Email
mahmoudalalfy@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Organizational Affiliation
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algazeerah and Kasralainy hospital
City
Giza
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Phone
+201002611058
Email
mahmoudalalfy@ymail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elgazzar, M.D
Phone
+201014005959
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Facility Name
Algazeerah
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Phone
+201002611058
Email
mahmoudalalfy@ymail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elgazzar, M.D
Phone
+201014005959
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Facility Name
Aljazeera( Al Gazeera) hospital
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Phone
+201002611058
Ext
+2
Email
mahmoudalalfy@ymail.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Laser in Treatment of Vulval Warts

We'll reach out to this number within 24 hrs