NCT03830047

Brief Summary

Vulval warts is a magor problem that affects women .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

February 2, 2019

Last Update Submit

August 4, 2019

Conditions

Vulval Wart

Outcome Measures

Primary Outcomes (1)

  • The number of women who will be completely cured by laser beam

    how laser will cure the warts

    within 2 months

Study Arms (2)

nd yag laser

ACTIVE COMPARATOR

Applying nd yag laser to vulva

Device: nd yag laser

Co2 laser

SHAM COMPARATOR

Applying CO2 laser to vulva

Device: nd yag laser

Interventions

nd yag laserDEVICE

nd yag laser will be applied on the vulval warts

Also known as: laser beam
Co2 lasernd yag laser

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales who have vulval warts
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • warts that were previously treated by surgery or cryotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Algazeerah and Kasralainy hospital

Giza, Egypt

NOT YET RECRUITING

Algazeerah

Giza, Egypt

RECRUITING

Aljazeera( Al Gazeera) hospital

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Lasers, Solid-StateLasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Mahmoud Alalfy, PhD

    Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Alalfy, PhD

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: applying laser for treatment of vulval warts
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 5, 2019

Study Start

February 7, 2019

Primary Completion

October 15, 2019

Study Completion

November 20, 2019

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

EG(3)