NCT04620785

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.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

November 3, 2020

Last Update Submit

July 23, 2021

Conditions

Verruca Vulgaris

Outcome Measures

Primary Outcomes (1)

  • disappearance of verruca

    clinical and dermoscopic cure

    10 weeks

Study Arms (3)

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

methylene blue / IPLOTHER

therapeutic

methylene blue/IPL
IPLOTHER

therapeutic

IPL
salineOTHER

placebo

saline

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University Faculty of Medicine

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Warts

Interventions

Methylene BlueSodium Chloride

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of dermatology

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

January 1, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations

EG(1)