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

NCT03460431 | Completed DMC

• 1 other identifier: 3060114
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Keloid

Outcome Measures

Primary Outcomes (3)

• comparison between different laser modalities in treatment of keloids clinically

  assessed by Patient and Observer Scar assessment Scale

  5 months

• 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

  5 months

• 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

  5 months

Study Arms (3)

fractional CO2 laser 10,600nm

EXPERIMENTAL

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

Device: fractional CO2 laser 10,600nm

Nd YAG laser 1064nm

EXPERIMENTAL

Nd YAG laser 1064nm

Device: Nd YAG laser1064 nm

combined two laser types

EXPERIMENTAL

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

Device: fractional CO2 laser 10,600nm; Device: Nd YAG laser1064 nm

Interventions

fractional CO2 laser 10,600nm DEVICE

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

combined two laser types; fractional CO2 laser 10,600nm

Nd YAG laser1064 nm DEVICE

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

Nd YAG laser 1064nm; combined two laser types

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shereen O Tawfik, MD

  professor of Dermatology.faculty of medicine. Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist of dermatology.students hospital. Cairo university

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 9, 2018
• Study Start: July 1, 2014
• Primary Completion: February 27, 2017
• Study Completion: June 30, 2017
• Last Updated: March 9, 2018

Record last verified: 2018-03