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
About this trial
This is an interventional treatment trial for Keloid
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
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
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
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