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

NCT02546076 | Withdrawn Phase 2

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

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.

Conditions

Keloid; Hypertrophic Scars

Keywords

Keloid; Hypertrophic scars; Er-YAG Lasers

Outcome Measures

Primary Outcomes (1)

• Any reduction from baseline of scars volume as assessed by image analysis

  24 weeks

Secondary Outcomes (5)

• Any reduction from baseline of scars volume as assessed by image analysis

  4, 8, 12, 16, 24 weeks

• Any improvement of scars as assessed by physician according to an ordinal 6-points scale

  4, 8, 12, 16, 24 weeks

• Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale

  16, 24 weeks

• Erythema index as assessed by image analysis

  4, 8, 12, 16, 24 weeks

• Hypopigmentation as assessed by image analysis

  4, 8, 12, 16, 24 weeks

Study Arms (2)

Laser coagulation

ACTIVE COMPARATOR

Er:YAG laser treatment with coagulation modality

Device: Laser coagulation

Laser w/o coagulation

ACTIVE COMPARATOR

Er:YAG laser treatment without coagulation modality

Device: Laser w/o coagulation

Interventions

Laser coagulation DEVICE

The treatment consists in performing Er:Yag laser with long-pulsed Erbium mode

Laser coagulation

Laser w/o coagulation DEVICE

The treatment consists in performing Er:Yag laser with true pulsed Erbium mode

Laser w/o coagulation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

MeSH Terms

Conditions

Keloid; Cicatrix, Hypertrophic

Interventions

Laser Coagulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Light Coagulation; Hemostatic Techniques; Therapeutics; Laser Therapy; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical; Ophthalmologic Surgical Procedures

Study Officials

• Maurice Adatto, MD

  Dep. of Dermatology, Inselspital University Hospital, Bern (Switzerland)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 10, 2015
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 14, 2017

Record last verified: 2017-04