search
Back to results

A Study Using Fractional Carbon Dioxide and Long Pulsed Neodymium-yttrium Aluminum Garnet Lasers in Treatment of Keloids

Primary Purpose

Keloid

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fractional CO2 laser 10,600nm
Nd YAG laser1064 nm
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    fractional CO2 laser 10,600nm

    Nd YAG laser 1064nm

    combined two laser types

    Arm Description

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

    Nd YAG laser 1064nm

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

    Outcomes

    Primary Outcome Measures

    comparison between different laser modalities in treatment of keloids clinically
    assessed by Patient and Observer Scar assessment Scale
    comparison between different laser modalities in treatment of keloids morphometrically
    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
    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 Outcome Measures

    Full Information

    First Posted
    January 23, 2018
    Last Updated
    March 4, 2018
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03460431
    Brief Title
    A Study Using Fractional Carbon Dioxide and Long Pulsed Neodymium-yttrium Aluminum Garnet Lasers in Treatment of Keloids
    Official Title
    Evaluation of Fractional CO2 and Non Ablative Long Pulsed Nd YAG Lasers Alone and in Combination in Treatment of Keloids
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2014 (Actual)
    Primary Completion Date
    February 27, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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: Complete history taking: History of disease onset, course and duration, family history as well as history of any systemic or dermatological disease interfering with the eligibility of participation in the study. Thirty patients were included in the study which is a clinical comparative study comparing the effectiveness of fractional CO2, long pulsed Nd YAG and their combination in collagen remodeling in keloid clinically in all the included patients and biochemically and immunohistochemically fifteen patient Full clinical examination: General examination to determine any systemic or dermatological disease that might preclude the patient from participation in the study such as collagen disease. Local examination to determine Fitzpatrick skin color of the patient and the site and extent of the scar to be treated. Methods: - Cases with multiple keloid scars three lesions 2 to 3 cm apart from each other were selected and labeled. The first one (lesion A) was treated using fractional CO2 laser 10,600 nm, the second (lesion B) long pulsed Nd YAG laser 1064 nm, while the last (lesion C) combined fractional CO2 followed by Nd YAG lasers after half an hour were used - patients who had a large sized lesion, the lesion was divided into three equal parts 2 to 3 cm apart from each other, they were labeled as areas A, B and C then subjected to the same treatment modalities as mentioned in case of multiple lesions. Patients received 4 treatment sessions 4 to 8 weeks apart. Laser modalities and parameters Topical anesthesia (lidocaine 2.5% and prilocaine 2.5%) was applied to the working area 30 to 60 minutes before the sessions, washed off and properly dried before the procedure. Ablative fractional 10,600 nm carbon dioxide laser (DEKA smartxide DOT, Italy) and long pulsed Nd-YAG (DEKA synchro FT) were used in the treatment sessions with the following parameters Fractional CO2 Stacking: 5, Power: 20 Watt, Dwell time: 1000 micro second, Spacing : 800 micro meter fluence: 40 j/cm2 Pulse duration: 0.3 milli second Spot size: 5 mm Passes: 3. Assessment Assessment was done before treatment every session and one months after the final laser treatment. Clinical assessment was done for all patients while histopathological and biochemical assessment were done only in 15 patients. A. Clinical evaluation Clinical assessment was fulfilled via calculating the scores of both the Vancouver Scar Scale; and the Patient and Observer Scar Assessment Scale. Patients were assessed every session, any side effects were reported, e.g pain, swelling, infection, hyper pigmentation or hypo pigmentation. B. Histopathological and biochemical evaluation Fifteen patients were randomly selected and subjected to the pre and post treatment biopsies : Pretreatment biopsy: Three mm punch skin biopsy was taken from the keloid (any lesion A, B, or C) before starting treatment sessions ●Post treatment biopsies: Each lesion (A, B, C) was biopsied separately (3 mm punch biopsy), one month after last treatment session. Biopsies of controls ●parts of excess skin from 12 patients undergoing abdominoplasty were used as controls for levels of TGFβ1 and TGFβ3. Procedure - Biopsies were fixed in 10 % neutral buffered formalin, and then embedded in paraffin blocks. Sections were prepared for routine staining by H&E. Other sections were prepared for histochemical staining of collagen fibres using Masson's trichrome stain and elastic fibres using orcein stain - All sections were examined using a Zeiss, Primo star light microscope (Zeiss, Germany). The microscope has an integrated camera by which photomicrographs depicting the various histopathological and histochemical findings were obtained. All photomicrographs presented in the thesis are according to their original magnification. • Evaluation of elastic fibres in orcein stained sections: Orcein stained sections were graded according to the grading criteria proved by Ozog et al. in 2013 for the appearance of the dermal elastic tissue as follows: 0 normal short fragmented elastic fibres intermediate between 1 and 3 fibrillar elastic fibres, parallel to epidermis intermediate between 3 and 5 absent or nearly absent. Image analyzer evaluation (morphometric study): The area percent of collagen and elastic fibres were quantitatively evaluated in Masson's trichrome and orcein stained sections respectively at magnification X100 in 5 non overlapping fields for all patients. Image analysis was done using Leica Qwin 500C image analyzer computer system (England) present in the Histology Department, Faculty of Medicine, Cairo University .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keloid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    fractional CO2 laser 10,600nm
    Arm Type
    Experimental
    Arm Description
    fractional CO2 laser 10,600nm one session every month for 4 months
    Arm Title
    Nd YAG laser 1064nm
    Arm Type
    Experimental
    Arm Description
    Nd YAG laser 1064nm
    Arm Title
    combined two laser types
    Arm Type
    Experimental
    Arm Description
    combined fractional CO2 laser 10,600nm and Nd YAG laser 1064nm lasers treatment to keloid
    Intervention Type
    Device
    Intervention Name(s)
    fractional CO2 laser 10,600nm
    Intervention Description
    fractional CO2 laser 10,600nm session, every month for 4 months
    Intervention Type
    Device
    Intervention Name(s)
    Nd YAG laser1064 nm
    Intervention Description
    Nd YAG laser1064 nm laser session, every month for 4 months
    Primary Outcome Measure Information:
    Title
    comparison between different laser modalities in treatment of keloids clinically
    Description
    assessed by Patient and Observer Scar assessment Scale
    Time Frame
    5 months
    Title
    comparison between different laser modalities in treatment of keloids morphometrically
    Description
    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
    Time Frame
    5 months
    Title
    comparison between different laser modalities in treatment of keloids biochemically
    Description
    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
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shereen O Tawfik, MD
    Organizational Affiliation
    professor of Dermatology.faculty of medicine. Cairo university
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Study Using Fractional Carbon Dioxide and Long Pulsed Neodymium-yttrium Aluminum Garnet Lasers in Treatment of Keloids

    We'll reach out to this number within 24 hrs