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

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ClinicalTrials.gov Identifier: NCT03460431
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Foad Mohamed, Cairo University

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

Condition or disease Intervention/treatment Phase
Keloid Device: fractional CO2 laser 10,600nm Device: Nd YAG laser1064 nm Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Fractional CO2 and Non Ablative Long Pulsed Nd YAG Lasers Alone and in Combination in Treatment of Keloids
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fractional CO2 laser 10,600nm
fractional CO2 laser 10,600nm one session every month for 4 months
Device: fractional CO2 laser 10,600nm
fractional CO2 laser 10,600nm session, every month for 4 months

Experimental: Nd YAG laser 1064nm
Nd YAG laser 1064nm
Device: Nd YAG laser1064 nm
Nd YAG laser1064 nm laser session, every month for 4 months

Experimental: combined two laser types
combined fractional CO2 laser 10,600nm and Nd YAG laser 1064nm lasers treatment to keloid
Device: fractional CO2 laser 10,600nm
fractional CO2 laser 10,600nm session, every month for 4 months

Device: Nd YAG laser1064 nm
Nd YAG laser1064 nm laser session, every month for 4 months




Primary Outcome Measures :
  1. comparison between different laser modalities in treatment of keloids clinically [ Time Frame: 5 months ]
    assessed by Patient and Observer Scar assessment Scale

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460431


Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Shereen O Tawfik, MD professor of Dermatology.faculty of medicine. Cairo university

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Responsible Party: Ahmed Foad Mohamed, specialist of dermatology.students hospital. Cairo university, Cairo University
ClinicalTrials.gov Identifier: NCT03460431     History of Changes
Other Study ID Numbers: 3060114
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes