Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy

NCT02985151 | Completed Results FDA Device

• 1 other identifier: SLU-27403
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of a fractionated carbon dioxide laser on surgical scars of the face and neck over 12 months. Anyone with a surgical scar on the face and neck who has not had laser therapy may be eligible to participate. The visits occur every three months for up to 12 months. Subjects will be randomly assigned to receive a higher energy treatment or a lower energy treatment during the study. Subjects and raters will be blinded to which therapy level the patient receives. At each visit, the scars will be photographed and the subject will complete a questionnaire to rate the scar prior to treatment. Three physicians will evaluate the scar at each visit. One rater will evaluate the scars in person during the visit, while the other two raters will evaluate the scars using photographs after each visit. During the first three study visits, subjects will receive their assigned treatment, obtain post-treatment instructions, and a diary to record redness, swelling, pain, itching, or other skin changes after treatment. At the third study visit, subjects will have the option to receive additional treatments or terminate their participation in the study. The fourth visit for those who continue will be a treatment visit for one group and the fifth visit will be for data collection, with no treatment offered.

Conditions

Cicatrix; Carbon Dioxide Laser

Keywords

Scar; Carbon Dioxide Laser; Laser Ablation

Outcome Measures

Primary Outcomes (10)

• Change in Vectra Measured Length V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group

  Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.

  3 months (month 0-3 for original randomized group, month 6-9 for crossover group)

• In Person Blinded Observer POSAS Change V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group

  Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.

  3 months (month 0-3 for original randomized group, month 6-9 for crossover group)

• Change in Vectra Measured Width V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group

  Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.

  3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)

• Change in Vectra Measured Surface Area V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group

  Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the surface area of the scar after laser therapy.

  3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)

• Change in Vectra Measured Length V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group

  Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.

  6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)

• Change in Vectra Measured Width V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group

  Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.

  6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)

• Change in Vectra Measured Surface Area V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group

  Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the suface area of the scar after laser therapy.

  6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)

• In-person Blinded Observer Change POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group

  Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.

  6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)

• Change in Blinded Photo Observer Score POSAS V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group

  Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by the blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.

  3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)

• Change in Blinded Photo Observer Score on POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group

  Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.

  6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)

Secondary Outcomes (1)

• Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group

  V1 (month 0) and V2 (month 3) for the original group; visit 3 (month 6) and visit 4 (month 9) for crossover group

Study Arms (2)

High Energy Treatment Group

ACTIVE COMPARATOR

Subjects in this group will receive at least two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group will be offered a third optional treatment at one of these settings.

Device: Syneron-Candela CO2RE Laser

Low Energy Placebo Group

PLACEBO COMPARATOR

Subjects in this group will receive at least two Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high energy treatments subsequent to receiving the two light energy treatments.

Device: Syneron-Candela CO2RE Laser

Interventions

Syneron-Candela CO2RE Laser DEVICE

This fractionated ablative laser will administer energy at either a high intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It will be operated by the principle investigator, who has extensive experience with laser therapy.

High Energy Treatment Group; Low Energy Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical scar present in the head or neck region for at least 8 weeks.
• Capable of providing informed consent
• Available for study appointments
• Follows directions of post-treatment instructions

You may not qualify if:

• Individuals under the age of 18
• Prior laser treatment to the head or neck
• History of keloid formation
• Isotretinoin use in the last 6 months prior to study enrollment
• Allergy to topical lidocaine
• Pregnant women

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University Department of Dermatology-Des Peres Med Arts Pavilion II

St Louis, Missouri, 63122, United States

Location

Related Publications (6)

• Omi T, Numano K. The Role of the CO2 Laser and Fractional CO2 Laser in Dermatology. Laser Ther. 2014 Mar 27;23(1):49-60. doi: 10.5978/islsm.14-RE-01.

  PMID: 24771971 BACKGROUND

• Bodendorf MO, Grunewald S, Wetzig T, Simon JC, Paasch U. Fractional laser skin therapy. J Dtsch Dermatol Ges. 2009 Apr;7(4):301-8. doi: 10.1111/j.1610-0387.2008.06845.x. Epub 2008 Aug 28. English, German.

  PMID: 18761608 BACKGROUND

• Chapas AM, Brightman L, Sukal S, Hale E, Daniel D, Bernstein LJ, Geronemus RG. Successful treatment of acneiform scarring with CO2 ablative fractional resurfacing. Lasers Surg Med. 2008 Aug;40(6):381-6. doi: 10.1002/lsm.20659.

  PMID: 18649382 BACKGROUND

• Majid I, Imran S. Fractional CO2 Laser Resurfacing as Monotherapy in the Treatment of Atrophic Facial Acne Scars. J Cutan Aesthet Surg. 2014 Apr;7(2):87-92. doi: 10.4103/0974-2077.138326.

  PMID: 25136208 BACKGROUND

• van der Wal MB, Tuinebreijer WE, Bloemen MC, Verhaegen PD, Middelkoop E, van Zuijlen PP. Rasch analysis of the Patient and Observer Scar Assessment Scale (POSAS) in burn scars. Qual Life Res. 2012 Feb;21(1):13-23. doi: 10.1007/s11136-011-9924-5. Epub 2011 May 20.

  PMID: 21598065 BACKGROUND

• Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.

  PMID: 15216537 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Two raters were used to rate the appearance of the scars. More raters will have been helpful.

Results Point of Contact

• Title: Research Manager/Coordinator
• Organization: Dermatology SLUCare Physician Group

rhonda.lebbing@health.slu.edu

314 977-1794

Study Officials

• Ramona Behshad, MD

  Saint Louis University, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Dermatology

Model Details: This is a crossover study where subjects are randomized into two arms. Subjects in the sham arm are allowed to crossover at the end of their initial intervention period.

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 6, 2023
• Results First Posted: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)