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NCT03392935 · OUTCOME

Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.

Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas · Source last updated 2023-05-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
12 Weeks

What was measured

Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).

Groups in this outcome

All Subjects

All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Subjects35

Analysis denominator · lesion

GroupSource count
All Subjects44

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Subjects-0.251.03Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.03
        value
        -0.25
denom Units Selected
lesion
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      44
    units
    lesion
description
Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).
dispersion Type
Standard Deviation
groups
  1. description
    All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
    id
    OG000
    title
    All Subjects
param Type
MEAN
reporting Status
POSTED
time Frame
12 Weeks
title
Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.
type
SECONDARY
type Units Analyzed
lesion
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice