Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 82 for:    acne AND Acne Scars

Comparison of 1550nm Fractional Laser Alone Versus in Combination With Microneedling for the Treatment of Acne Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03901417
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Mathew Avram, MD, JD, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Acne Scars Device: Fraxel Restore (Non-ablative Fractional Laser) Device: Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized split-face clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Active Comparator: Non-ablative Fractional Laser
Non-ablative fractional laser (brand name Fraxel Restore) only on one half of the face.
Device: Fraxel Restore (Non-ablative Fractional Laser)
In the study, one side of the face will be treated with non-ablative fractional laser monthly for three months.

Active Comparator: Non-ablative Fractional Laser Plus Microneedling
Non-ablative fractional laser (brand name Fraxel Restore) in combination with a microneedling device (SkinPen) on the other half of the face.
Device: Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device)
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 Measures :
  1. Improvement in acne scarring [ Time Frame: 20 weeks ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Layout table for additonal information
Responsible Party: Mathew Avram, MD, JD, Director, Dermatologic Surgery and Laser and Cosmetic Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03901417     History of Changes
Other Study ID Numbers: 2018P002595
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes