- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985151
Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy
A Single Center, Double-blinded Randomized Placebo-controlled Trial to Evaluate Surgical Scars After Treatment With Fractional Carbon Dioxide Rejuvenation Laser Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In dermatology, the use of Light Amplification by Stimulated Emission of Radiation (laser) has revolutionized the management of various conditions including angiomas, vitiligo, wrinkles, and scars. (Omi, 2014 and Chapas, 2008) Scars result from sub-optimal collagen production during wound healing leading to topographical irregularities. To effectively modify these defects, any treatment must be capable of penetrating the epidermis and eliciting dermal remodeling at a depth of at least 1 mm. The 10,600 nm carbon dioxide (CO2) laser utilizes high energy at short durations to vaporize intra- and extra-cellular water, resulting in tissue ablation causing a substantial thermal injury to the dermis, reducing the likelihood of additional scarring. The CO2 laser can stimulate collagen production and theoretically improve scar thickness, pliability, and texture.
This study is a prospective, randomized double-blinded placebo-controlled trial to evaluate the efficacy of fractionated carbon dioxide laser in improving surgical scars on the head and neck over 3-5 study visits for a duration of 12.5 months. Scar assessments will be based on objective changes identified on pictures taken with the Canfield Vectra M3 3D Imaging System and subjective changes identified with the Patient and Observer Scar Assessment Scale (POSAS), a validated scar scale. As a secondary objective, the study will evaluate the tolerability of the laser, by assessing the severity and duration of known side effects of laser therapy such as erythema, edema, burning sensation, post-inflammatory pigment changes, infection, scarring, xerosis, pruritus, bronzing, and any other adverse events that arise following treatment. Subjects will be given a diary after each treatment to document this information.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Missouri
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Saint Louis, Missouri, United States, 63122
- Saint Louis University Department of Dermatology-Des Peres Med Arts Pavilion II
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High Energy Treatment Group
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.
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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.
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Placebo Comparator: Low Energy Placebo Group
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 3 months (month 0-3 for original randomized group, month 6-9 for crossover group)
|
Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.
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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
Time Frame: 3 months (month 0-3 for original randomized group, month 6-9 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
Time Frame: 3 months (months 0-3 for the original randomized group, months 6-9 for the 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
Time Frame: 3 months (months 0-3 for the original randomized group, months 6-9 for the 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
Time Frame: 6 months (months 0-6 for the original randomized group, months 6-12 for the 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
Time Frame: 6 months (months 0-6 for the original randomized group, months 6-12 for the 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
Time Frame: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)
|
Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the suface area of the scar after laser therapy.
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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
Time Frame: 6 months (months 0-6 for the original randomized group, months 6-12 for the 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
Time Frame: 3 months (months 0-3 for the original randomized group, months 6-9 for the 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
Time Frame: 6 months (months 0-6 for the original randomized group, months 6-12 for the 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: V1 (month 0) and V2 (month 3) for the original group; visit 3 (month 6) and visit 4 (month 9) for crossover group
|
Participants will be given a diary to record the severity and duration of symptoms for the day of treatment and then daily for seven days after each laser treatment: redness, scaling/flaking, pustules, swelling, pain, itching, burning, color changes (darkening and/or lightning), infection, and any other adverse events that arise following treatment.
Subjects score each of the symptom severity on a scale of 0-4 (0=none, 1= mild, 2= moderate, 3= intense, 4= intolerable).
The average weekly score for each group is reported below.
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V1 (month 0) and V2 (month 3) for the original group; visit 3 (month 6) and visit 4 (month 9) for crossover group
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ramona Behshad, MD, Saint Louis University, Department of Dermatology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLU-27403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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