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Clinical Trials/NCT03460431
NCT03460431CompletedNot Applicable

Evaluation of Fractional CO2 and Non Ablative Long Pulsed Nd YAG Lasers Alone and in Combination in Treatment of Keloids

Cairo University0 sites30 target enrollmentStarted: July 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Primary Endpoint
comparison between different laser modalities in treatment of keloids clinically

Study Overview

Brief Summary

clinical comparative study comparing the effectiveness of fractional CO2, long pulsed Nd YAG and their combination in collagen remodeling in keloid clinically, biochemically and histopathologically

Detailed Description

Patients The study included 30 Egyptian patients with keloid scar recruited from the Out Patient Clinic, Dermatology Department, Cairo University.

Methodology

Patients:

  • Thirty patients with keloid scar(s) were included in the study

  • Every patient was subjected to the following:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with keloid scars of at least 6 months duration.
  • No limitations regarding sex of the patients.
  • Patients with three or more lesions 2 to 3 cm apart or patients having a large sized lesion.

Exclusion Criteria

  • Patients who had received any form of treatment during the last four weeks prior to treatment such as intralesional steroids or a laser procedure during the last six months.
  • Patients with active skin infections e.g. herpes or autoimmune disease.
  • Patients with previous history of adverse outcome related to laser therapy.
  • Recent use of Isotretinoin (within 6 months prior to the procedure).
  • Patients with known allergies to lidocaine.
  • Smoking, pregnancy
  • Patients with unrealistic expectations

Arms & Interventions

fractional CO2 laser 10,600nm

Experimental

fractional CO2 laser 10,600nm one session every month for 4 months

Intervention: fractional CO2 laser 10,600nm (Device)

Nd YAG laser 1064nm

Experimental

Nd YAG laser 1064nm

Intervention: Nd YAG laser1064 nm (Device)

combined two laser types

Experimental

combined fractional CO2 laser 10,600nm and Nd YAG laser 1064nm lasers treatment to keloid

Intervention: fractional CO2 laser 10,600nm (Device)

combined two laser types

Experimental

combined fractional CO2 laser 10,600nm and Nd YAG laser 1064nm lasers treatment to keloid

Intervention: Nd YAG laser1064 nm (Device)

Outcomes

Primary Outcomes

comparison between different laser modalities in treatment of keloids clinically

Time Frame: 5 months

assessed by Patient and Observer Scar assessment Scale

comparison between different laser modalities in treatment of keloids morphometrically

Time Frame: 5 months

assessed by Quantitative morphometric analysis using Leica Qwin 500 Image Analyzer (LEICA Imaging Systems Ltd, Cambridge, England) measuring area percent of collagen and elastin fibers in micrometer squared

comparison between different laser modalities in treatment of keloids biochemically

Time Frame: 5 months

assessed by level of transforming growth factor beta 1 and 3 using Human TGF-B ELISA kit provided by ID labs Biotechnology London, ON, Canada.measurement unit is nano gram per gram tissue

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Foad Mohamed

specialist of dermatology.students hospital. Cairo university

Cairo University

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