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Comparison of Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars (KELOID)

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ClinicalTrials.gov Identifier: NCT02546076
Recruitment Status : Withdrawn (Lack of patients)
First Posted : September 10, 2015
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

Skin injuries due to trauma are relatively common, and patients are very concerned about scars caused by trauma and primary repair. Recently, the use of ablative and non-ablative lasers based on the fractional approach has become a novel strategy for the treatment of scars.

The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering pulses either with and without heat/coagulation in a cohort of patients with long keloid/hypertrophic scars.

The main hypothesis is that ablative fractional laser without heat/coagulation is equivalent to laser with heat/coagulation in terms of scars volume reduction, while the secondary hypothesis is that ablative fractional laser without heat/coagulation is superior in terms of post-operative erythema and hypopigmentation reduction.


Condition or disease Intervention/treatment Phase
Keloid Hypertrophic Scars Device: Laser coagulation Device: Laser w/o coagulation Phase 2

Detailed Description:

Background

Skin injuries, such as lacerations or abrasions, due to trauma are relatively common, and patients are very concerned about scars caused by trauma and primary repair. Multiple modalities for improving the clinical appearance of scars have been attempted with varying success, including corticosteroids, dermabrasion, surgical revision, chemical peeling, silicone gel application, pressure therapy, and radiation. Lasers such as the carbon dioxide (CO2), erbium: yttrium-aluminum-garnet (Er:YAG), and pulsed dye (PDL) lasers have all been used with differing success in the treatment of scars. The goal of all these treatments is to soften depressions and stimulate neocollagenesis in order to fill in the residual defects.

Ablative lasers used for skin resurfacing, such as the CO2 and Er:YAG laser, can reduce various scars, but significant adverse effects limit their use, and patient downtime can be extensive. Owing to these potential risks, nonablative lasers have been developed as a safe alternative to ablative laser resurfacing, and have been reported to be effective and safe for scars. However outcomes have remained unsatisfactory and require several treatments to achieve satisfactory efficacy.

Recently, the use of ablative and non-ablative lasers based on the fractional approach has become a novel strategy for the treatment of scars, and some authors have suggested that treatment with fractional lasers for various scars, such as postoperative, atrophic, and acne scars, has been demonstrated to safely improve the appearance of the scars. However, there is a lack of studies comparing coagulation modality of such lasers.

Objective

The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering pulses either with and without heat/coagulation in a cohort of patients with long keloid/hypertrophic scars.

Methods

This is a single center, investigator initiated, double blind, within-subject split-lesion design, equivalence randomized clinical study.

Consecutive patients, referring to Dermatology outpatient and fulfilling inclusion criteria, are included. Participants are then randomly assigned to get treatment with Er:YAG laser on half of scar section side by equally splitting the lesion area in two symmetric and uniform parts. One side will be treated with coagulation while the other one will be without. In case of multiple lesions per patient, only the largest and most uniform one is selected for the study purpose.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Within-subject Randomized Clinical Trial Comparing Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars
Actual Study Start Date : May 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Active Comparator: Laser coagulation
Er:YAG laser treatment with coagulation modality
Device: Laser coagulation
The treatment consists in performing Er:Yag laser with long-pulsed Erbium mode

Active Comparator: Laser w/o coagulation
Er:YAG laser treatment without coagulation modality
Device: Laser w/o coagulation
The treatment consists in performing Er:Yag laser with true pulsed Erbium mode




Primary Outcome Measures :
  1. Any reduction from baseline of scars volume as assessed by image analysis [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Any reduction from baseline of scars volume as assessed by image analysis [ Time Frame: 4, 8, 12, 16, 24 weeks ]
  2. Any improvement of scars as assessed by physician according to an ordinal 6-points scale [ Time Frame: 4, 8, 12, 16, 24 weeks ]
  3. Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale [ Time Frame: 16, 24 weeks ]
  4. Erythema index as assessed by image analysis [ Time Frame: 4, 8, 12, 16, 24 weeks ]
  5. Hypopigmentation as assessed by image analysis [ Time Frame: 4, 8, 12, 16, 24 weeks ]


Information from the National Library of Medicine

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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:

  • Given written informed consent
  • Skin type I-IV
  • Presence of long keloid/hypertrophic scar of at least 3 cm² and of uniform/symmetric type
  • Willingness and ability to adhere study protocol

Exclusion Criteria

  • History of adverse events related to ablative fractional laser therapy
  • Ablative resurfacing within the last 6 months on the scar
  • Oral retinoid, any immunosuppressive treatments in the last 6 months
  • Pregnancy, lactation

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): NCT02546076


Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Maurice Adatto, MD Dep. of Dermatology, Inselspital University Hospital, Bern (Switzerland)

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02546076     History of Changes
Other Study ID Numbers: KELOID
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by University Hospital Inselspital, Berne:
Keloid
Hypertrophic scars
Er-YAG Lasers

Additional relevant MeSH terms:
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Hypertrophy
Keloid
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes