Vulval WartNCT03830047
Effect of Laser in Treatment of Vulval Warts
A study testing nd yag laser in people with Vulval Wart, run by Aljazeera Hospital at 3 sites in Egypt.
Trial summary
Vulval warts is a magor problem that affects women . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulval Wart
- What is being tested?
- nd yag laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesEgypt
- Study dates
- 7 Feb 2019to 20 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women who have vulval warts
- Age between 18- 40 years
Who cannot join
- warts that were previously treated by surgery or cryotherapy
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Not yet recruiting
Algazeerah and Kasralainy hospital
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
- Recruiting
Aljazeera( Al Gazeera) hospital
Giza
Mahmoud Alalfy, PhD, +201002611058 ext. +2, mahmoudalalfy@ymail.com
About this study
Official title: Effect of nd Yag Laser in Treatment of Vulval Warts
Vulval warts is a magor problem that affects women .
Read the detailed description
The causative organism for vulval warts is human papilloma virus There are many treatment modalities that can trat these warts
- Conditions
- Vulval Wart
- Being tested
- nd yag laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nd yag laserDevice
Also called laser beam
nd yag laser will be applied on the vulval warts
| Study group | Role | What they receive |
|---|---|---|
| nd yag laser | Active comparator | Applying nd yag laser to vulva Receives: Device: nd yag laser |
| Co2 laser | Sham comparator | Applying CO2 laser to vulva Receives: Device: nd yag laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will be completely cured by laser beam
how laser will cure the warts
Measured: within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start7 Feb 2019
- Primary completion15 Oct 2019 (estimated)
- Study completion20 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulval WartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- applying laser for treatment of vulval warts
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830047
- Sponsor's protocol ID
- laser
- Status last verified
- Aug 2019
- First submitted
- 2 Feb 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of nd Yag Laser in Treatment of Vulval Warts
- ClinicalTrials.gov ID
- NCT03830047
- Acronym / sponsor ID
- laser
- Conditions
- Vulval Wart
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 20 Nov 2019 (estimated)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- applying laser for treatment of vulval warts
| Arm | Type | Receives |
|---|---|---|
| nd yag laser | Active comparator | Device: nd yag laserApplying nd yag laser to vulva |
| Co2 laser | Sham comparator | Device: nd yag laserApplying CO2 laser to vulva |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women who have vulval warts
- Age between 18- 40 years
Key exclusion criteria (1 listed)
- warts that were previously treated by surgery or cryotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nd yag laserAlso: laser beamnd yag laser will be applied on the vulval warts | Device | Co2 laser, nd yag laser |
Primary outcome
The number of women who will be completely cured by laser beam
Time frame: within 2 months
how laser will cure the warts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alalfy, PhD principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nd yag laser in people with Vulval Wart, run by Aljazeera Hospital at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Alalfy, PhD (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women who will be completely cured by laser beam (time frame: within 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.