Photodynamic Therapy in Treatment of Verrucae | NCT04620785

Studies
Photodynamic Therapy in Treatment of Verrucae

NCT04620785

Sponsor

Alexandria University

Status

Unknown status

Last Update Posted

Jul 26, 2021Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Verruca Vulgaris

Interventions

methylene blue / IPL
IPL
saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

May 1, 2022Estimated

Completion Date

May 1, 2022Estimated

First Submitted Date

Nov 3, 2020

First Submission Date that Met QC Criteria

Nov 3, 2020

First Posted Date

Nov 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2021

Last Update Posted Date

Jul 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the efficacy (clinically and dermoscopically) and safety of photodynamic therapy using intralesional injection of 4% methylene blue solution as a photosensitizer with IPL versus IPL only in treatment of warts.

Detailed Description

This study will be conducted on:

Eighty patients suffering of verruca (male and female) divided randomly into three groups: group A, B&C :

Group A: 30 patients will undergo photodynamic therapy using intralesional 4%methylene blue solution and IPL.

Group B: 30 patients will undergo IPL only. Group C (control group):20 patients will undergo intralesional saline.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
methylene blue/IPL	Experimental	will undergo photodynamic therapy using intralesional 4%methylene blue solution ,after a period of 15 minutes the patient will be subjected to IPL session. This will be repeated biweekly until complete clearance of the lesion or a maximum four sessions.	Other: methylene blue / IPL
IPL	Experimental	will undergo biweekly IPL sessions only until complete clearance of the lesion or a maximum four sessions.	Other: IPL
saline	Placebo Comparator	will undergo intralesional saline.	Other: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
methylene blue / IPL	Other	therapeutic	methylene blue/IPL
IPL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disappearance of verruca	clinical and dermoscopic cure	10 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age:Above 16 years old.
Sex:Both males and female patients.
Clinically and dermoscopically documented verruca.
No verruca treatment in the last 2 weeks.

Exclusion Criteria:

History of photosensitivity disorder.
Pregnant and lactating females.
Diseases with risk of koebnerization e.g. Psoriasis and Lichen planus.
Anogenital warts.
Warts on head and neck.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandria University Faculty of Medicine	Recruiting	Alexandria			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014860	Warts

Ancestor Terms

ID	Term
D030361	Papillomavirus Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008751	Methylene Blue
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D010640	Phenothiazines
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006575	Heterocyclic Compounds, 3-Ring

Browse Leaves

Not provided

Browse Branches

Not provided