Comparison of 1550nm Fractional Laser Alone Versus in Combination With Microneedling for the Treatment of Acne Scars
Primary Purpose
Acne Scars
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fraxel Restore (Non-ablative Fractional Laser)
Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device)
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars
Eligibility Criteria
Inclusion Criteria:
- All gender patients
- Age older than 18 years
- Fitzpatrick skin types I-III
- Facial acne scarring of grades III-IV
- Both sides of the face should have similar amount and severity of acne scarring
Exclusion Criteria:
- History of keloidal scarring
- Localized or active infection in the treatment region
- Immunodeficiency disorders
- Porphyria or light sensitivity
- Connective tissue disorders.
- Pregnant or nursing
- Recent isotretinoin use within the past 6 months
- Renal Disease
- Allergies to lidocaine, tetracaine, valacyclovir
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Non-ablative Fractional Laser
Non-ablative Fractional Laser Plus Microneedling
Arm Description
Non-ablative fractional laser (brand name Fraxel Restore) only on one half of the face.
Non-ablative fractional laser (brand name Fraxel Restore) in combination with a microneedling device (SkinPen) on the other half of the face.
Outcomes
Primary Outcome Measures
Improvement in acne scarring
Two blinded evaluators will use standardized digital photographic review to grade acne scar improvement on a quartile grading scale (1 = 1% to 25%, 2 = 26 to 50%, 3 = 51 to 75%, 4 = >76% improvement).
Secondary Outcome Measures
Full Information
NCT ID
NCT03901417
First Posted
March 26, 2019
Last Updated
January 27, 2020
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03901417
Brief Title
Comparison of 1550nm Fractional Laser Alone Versus in Combination With Microneedling for the Treatment of Acne Scars
Official Title
A Randomized, Double-blind, Split-face Controlled Pilot Study to Assess the Efficacy of Combination Microneedling and Non-ablative Fractional Laser Versus Non-ablative Fractional Laser Alone for Treatment of Atrophic Acne Scars
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Acne scarring is an unfortunate consequence of inflammatory acne vulgaris that often leads to significant cosmetic and psychosocial impacts. Although there have been many advances in the treatment of acne scarring, it remains one of the greatest challenges in cosmetic and laser dermatology.
There have been a multitude of studies establishing the efficacy of non-ablative fractional laser therapy for the treatment of atrophic acne scars, and it is widely regarded as one of the best available treatments. More recently, there has been a renewed interest in controlled, non-thermal dermal injury via microneedling devices in the treatment of atrophic acne scars.
Where there is a gap in the literature, however, is in the evaluation of the combination of non-ablative fractional laser resurfacing with microneedling in the treatment of atrophic acne scars.
The investigators' study will compare the safety and efficacy of using non-ablative fractional laser versus a combination of microneedling and non-ablative fractional laser for atrophic acne scars using a randomized, double-blind, split-face study.
The investigators' aim is to further elucidate the pathogenesis of acne scarring and the best approaches for treatment. In doing so, the investigators will study a combination approach to this complex problem in order to better serve future patients.
Detailed Description
Acne vulgaris is a highly prevalent dermatologic disorder that affects up to 90% percent of the population at some point in their lives to varying degrees. Acne scarring is an unfortunate complication of the inflammation that results if acne is not sufficiently treated. Classically, acne scarring has been described as either atrophic, hypertrophic, keloidal, or pigmented. Atrophic is by far the most common type of acne scarring and is subdivided into boxcar, rolling, and icepick subtypes. The presence of acne scarring has been associated with a significant decrease in patient well-being and has many psychosocial implications. Although the understanding of the pathogenesis, prevention, and treatment of acne scarring has come a long way, there are limitations to the current treatment options and the search for a cure continues.
One of the greatest advances in the treatment of acne scarring came with the advent of non-ablative fractional lasers, which work through the theory of fractional photothermolysis. Fractional photothermolysis relies on the principle of creating thousands of microthermal injury zones in the skin while allowing the surrounding intact skin to expedite wound healing. The relative sparing of the epidermis while facilitating collagen remodeling in the dermis underlies the use of non-ablative fractional laser therapy in the treatment of atrophic scars.
The erbium-doped 1,550-nm non-ablative fractional laser has been extensively studied in the treatment of atrophic acne scars with good efficacy and safety.
The concept of using needle subcision for the treatment of depressed surgical scars was first described by Orentreich et al in 1995. The first microneedling device, a drum-shaped roller was subsequently developed by Fernandes et al in the early 2000s. Several studies have validated the use of microneedling for acne scarring with a similar mechanism of creating microchannels in the dermis that allow for collagen remodeling. Furthermore, microneedling has been demonstrated to induce a specific cytokine profile including fibroblast-like growth factor, vascular endothelial growth factor, epidermal growth factor, and transforming growth factor-beta3 which are associated with favorable wound healing.
More recently, experts have advocated for the use of electric-powered microneedling devices which allow for more controlled injury at a set depth, density, and speed for the treatment of atrophic acne scars with good results.
To the investigators' knowledge, this study will be the first of its kind to compare the efficacy and safety of a combination of 1,550-nm erbium-doped fractional laser and microneedling with the SkinPenTM device to 1,550-nm erbium-doped fractional laser alone in the treatment of atrophic acne scars.
Both treatment modalities in this study are already FDA approved treatment modalities for acne scarring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized split-face clinical trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-ablative Fractional Laser
Arm Type
Active Comparator
Arm Description
Non-ablative fractional laser (brand name Fraxel Restore) only on one half of the face.
Arm Title
Non-ablative Fractional Laser Plus Microneedling
Arm Type
Active Comparator
Arm Description
Non-ablative fractional laser (brand name Fraxel Restore) in combination with a microneedling device (SkinPen) on the other half of the face.
Intervention Type
Device
Intervention Name(s)
Fraxel Restore (Non-ablative Fractional Laser)
Intervention Description
In the study, one side of the face will be treated with non-ablative fractional laser monthly for three months.
Intervention Type
Device
Intervention Name(s)
Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device)
Intervention Description
In the study, one side of the face will be treated with a combination of non-ablative fractional laser and microneedling monthly for three months.
Primary Outcome Measure Information:
Title
Improvement in acne scarring
Description
Two blinded evaluators will use standardized digital photographic review to grade acne scar improvement on a quartile grading scale (1 = 1% to 25%, 2 = 26 to 50%, 3 = 51 to 75%, 4 = >76% improvement).
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All gender patients
Age older than 18 years
Fitzpatrick skin types I-III
Facial acne scarring of grades III-IV
Both sides of the face should have similar amount and severity of acne scarring
Exclusion Criteria:
History of keloidal scarring
Localized or active infection in the treatment region
Immunodeficiency disorders
Porphyria or light sensitivity
Connective tissue disorders.
Pregnant or nursing
Recent isotretinoin use within the past 6 months
Renal Disease
Allergies to lidocaine, tetracaine, valacyclovir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathew Avram, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of 1550nm Fractional Laser Alone Versus in Combination With Microneedling for the Treatment of Acne Scars
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