NCT06347081

Brief Summary

A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months. T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

March 27, 2024

Last Update Submit

April 2, 2024

Conditions

Keywords

Nd-YAG laser

Outcome Measures

Primary Outcomes (2)

  • hypertrophic scar maturation

    Changes in the scars' color, vascularity, elevation, and pliability were evaluated and scored using the Vancouver scale (VSS). VSS is from 0 to 14. A lower value indicates a better scar.

    before treatment,12 weeks, and then 28 weeks of the treatment.

  • hypertrophic scar volume

    Scar volume was determined using the negative-positive moulage method.

    before treatment,12 weeks, and then 28 weeks of the treatment.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients received standard medical care, nursing, physiotherapy, and a sham laser during the course of treatment

Procedure: Nd- YAG laser at 532nm wavelength

Laser group

ACTIVE COMPARATOR

Patients received 532 nm laser radiation in addition to standard medical care, nursing, and physiotherapy.

Procedure: Nd- YAG laser at 532nm wavelength

Interventions

Nd-YAG laser at 532nm wavelength every 2 weeks for 14 sessions. patients will also receive standard medical care, nursing, physiotherapy

Laser groupPlacebo

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients with hypertrophic scars.

You may not qualify if:

  • Patients were excluded if they had taken oral retinoids in the last year.
  • Patients had any skin defects.
  • Patients had any history of photosensitivity.
  • Patients experienced active skin diseases in the treatment regions (such as psoriasis, cancer, or autoimmune disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: one treatment one control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assis prof of rehabilitation

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 4, 2024

Study Start

May 1, 2022

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations