Photodynamic Therapy in Treatment of Verrucae

Plain-language guide to NCT04620785: not phased randomized trial of Methylene blue (non-peptide stack partner), 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04620785
Phase: not phased
Status: status unknown
Start: 2020-01-01
Completion (planned or actual): 2022-05-01
Participants: 80 (estimated)
Design: randomized, single-blind, treatment
Conditions studied: Verruca Vulgaris
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

It had three arms (groups): methylene blue/IPL (experimental), IPL (experimental) and saline (placebo comparator).

Will undergo biweekly IPL sessions only until complete clearance of the lesion or a maximum four sessions.

Will undergo intralesional saline.

The registry classes the interventions as other.

More on the Plan

Group B: 30 patients will undergo IPL only.

Group C (control group):20 patients will undergo intralesional saline.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to people of any sex aged from 16 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

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

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: history of photosensitivity disorder; pregnant and lactating females; diseases with risk of koebnerization e.g. psoriasis and lichen planus.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Methylene blue (non-peptide stack partner) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2020-01-01 with completion listed for 2022-05-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): disappearance of verruca (time frame: 10 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 80 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Methylene blue (non-peptide stack partner) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.