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Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin

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ClinicalTrials.gov Identifier: NCT03380845
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : October 25, 2019
Sponsor:
Collaborator:
American Society for Dermatologic Surgery
Information provided by (Responsible Party):
Mathew Avram, MD, JD, Massachusetts General Hospital

Brief Summary:

The primary objective of this randomized, split-face, controlled study is to compare the efficacy and safety of a erbium-doped 1,550-nm non-ablative fractional laser and a bipolar fractional radiofrequency microneedle device for the treatment of atrophic facial acne scars in ethnic skin (Fitzpatrick Skin Phototypes III-VI).

The hypothesis of this study is that both erbium-doped 1,550-nm non-ablative fractional laser and the bipolar fractional radiofrequency microneedle device are equally effective for the treatment of atrophic acne scars in ethnic skin (SPT III-VI). However, the bipolar fractional radiofrequency microneedle device has less adverse effects than erbium-doped 1,550-nm non-ablative fractional laser due to the absence of scattering and the absence of chromophore-specific targets - predominantly melanin - traditionally needed with laser treatments; hence the fractional radiofrequency microneedle device will have a higher safety profile in darker skin types .


Condition or disease Intervention/treatment Phase
Acne Scars Device: Fraxel Restore Device: Fractora Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized split-face clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Fractional Erbium-Doped 1,550-nm Laser and a Bipolar Fractional Radiofrequency Microneedle Device for the Treatment of Atrophic Acne Scars in Ethnic Skin: A Randomized Split-Face Controlled Pilot Study
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Active Comparator: Fraxel Restore

Multiple published studies have demonstrated that erbium-doped 1,550-nm non-ablative fractional laser ("NAFL") can be successfully utilized in the treatment of all forms of atrophic acne scarring - ice-pick, boxcar, and rolling scars - with a very favorable safety profile in all skin types, and thus, has been cleared by Food and Drug Administration (FDA) for that particular indication. According to the manufacture manual (reference attached in the "Documents and Attachments" section), NAFL is indicated for "use in skin resurfacing procedures as well as treatment of acne scars, surgical scars, lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma."

Fraxel Restore to be done on one side of the face monthly for three months.

Device: Fraxel Restore
Non-ablative Laser. In the study, one side of the face will be treated with Fraxel Restore monthly for three months.

Active Comparator: Fractora

Fractional radiofrequency is not a laser. Instead, these devices use an array of electrodes that allows for zones of thermal wounds to be created between areas of unaffected zones, thus stimulating dermal remodeling and allowing for a supply of reservoir cells to promote healing. Great interest has been culminating over the recent years for the use of such devices in acne scars due to the absence of light scattering and the absence of chromophore-specific targets traditionally needed with laser treatments. As melanin is not a target, it is felt to have a higher safety profile in darker skin phototypes.

Fractora to be done on one side of the face monthly for three months.

Device: Fractora
Fractional Radiofrequency Microneedling Device. In the study, one side of the face will be treated with Fractora monthly for three months.




Primary Outcome Measures :
  1. Improvement in acne scarring [ Time Frame: 3 months after the last treatment ]
    Improvement in acne scarring will be measured by two blinded evaluators both by in-person assessments and by photographic review (digital photography will be used under standardized conditions). A quartile grading scale (1 = 1% to 25%, 2 =26% to 50%, 3 =51% to 75%, 4 = >76% improvement) will be used to measure acne scar improvement.


Secondary Outcome Measures :
  1. Comparing side effects of the different lasers [ Time Frame: 6 months ]
    measure side effects by patient reported adverse events and blinded physician assessment of adverse effects. Parameters, include erythema, edema, blistering, crusting, scarring, hypopigmentation, and hyperpigmentation, will be graded on a 4-point scale (0 = absent, 1= mild, 2 = moderate, and 3 = severe).

  2. Comparing intensity of pain with the different lasers [ Time Frame: 6 months ]
    Patients will also be evaluated the intensity of pain using a visual analogue scale (0 = absence of pain, 10 = most-severe pain).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women with Fitzpatrick skin types III through VI and facial acne scarring of grades III-IV will be enrolled. Both sides of the participants' face should have almost similar amount and severity of acne scarring. Participants will be over 18 years old

Exclusion Criteria:

  • Patients have to be overall healthy without a history of keloidal scarring, localized or active infection in the treatment region, immunodeficiency disorders, porphyria or light sensitivity, and connective tissue disorders. Per PI discretion, any serious medical condition that may interfere with the study. In addition, pregnant or nursing women, patients who have been taking isotretinoin for a period of 6 months before treatment, and patients who have received any cosmetic treatment (lasers, dermabrasion, chemical peels, etc) in the previous 6 months will be excluded. Also, patients with renal disease, and any allergies to Lidocaine, Tetracaine, or Valtrex will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380845


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
American Society for Dermatologic Surgery
Investigators
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Principal Investigator: Mathew Avram, MD MGH

Publications:

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Responsible Party: Mathew Avram, MD, JD, Director, MGH Laser, Cosmetic and Dermatologic Surgery, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03380845     History of Changes
Other Study ID Numbers: 2017P002061
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019

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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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes