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Acne Scarring in Skin of Color: Laser vs Microneedling

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ClinicalTrials.gov Identifier: NCT03395678
Recruitment Status : Not yet recruiting
First Posted : January 10, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Boston University

Brief Summary:
Atrophic acne scars are a common and important sequelae of acne that affect up to 43-55% of patients with acne. Scarring impacts quality of life with reports of diminished self-esteem and frustration/sadness; additionally, some individuals report that their appearance even interferes with their professional lives. Though many treatments for acne scarring exist including ablative and nonablative lasers, subcision, and peels, none is without risk of adverse effects of pain, post-procedure redness or pigmentary changes. There have been no randomized studies directly comparing the effectiveness and safety profiles of microneedling (Dermapen) to 1,540nm nonablative fractional lasers (Palomar StarLux) in the treatment of atrophic acne scarring in skin of color. This clinical trial aims to determine which treatment modality -- microneedling or nonablative fractional laser -- is safer and more efficacious in the treatment of acne scarring in patients with skin of color.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Scar Device: Microneedling Device: Fractional non-ablative 1,540nm laser Not Applicable

Detailed Description:

This is a randomized, prospective clinical trial of 30 healthy patients with Fitzpatrick skin phototypes III-V with atrophic acne scars on the face who desire treatment of their scars. Subjects with skin phototypes III - V are being studied because this population has been underrepresented in literature on treatment of acne scarring and also has been shown to have a higher incidence of adverse effects including post-inflammatory hyperpigmentation from established treatments for acne scarring such as ablative laser resurfacing. Each treatment group of 15 subjects will be composed of 5 patients each with skin type III, IV, and V.

Participants will have a total of 7 visits lasting between thirty minutes to one hour in duration. The first visit will be an assessment for inclusion in the study. Once consented participants will randomized to either the laser arm that will be treated with a 1,540nm fractional nonablative laser (Palomar StarLux) or the microneedling arm that will be treated with a microneedling device (Dermapen 3MD). The precise laser or microneedling settings will be tailored to each participant. After enrollment and prior to the first treatment session, participants in both groups will pretreat with adapalene 0.1% gel, hydroquinone 2% cream, and sunscreen to the face daily for 4 weeks prior to first treatment. This is an acceptable pre-treatment protocol in the treatment of acne scarring.

Participants will receive a series of 5 treatment sessions of either the laser or microneedling per randomization protocol at 4-6 week intervals. At each visit, participants will be asked about any adverse effects and also examined by either the PI or co-investigator. If any adverse effects are noted, subjects will have the option of either continuing or discontinuing their involvement in the study. Standardized high-resolution digital photographs of all patients will be taken at baseline (pre-treatment) and 3 months after the last treatment session. At that 3 months follow up participants will also be asked to complete a questionnaire about their treatment experiences and satisfaction with the outcome and the Dermatology Life Quality Index questionnaire. If the study reveals that one treatment modality is far superior to the other treatment, participants randomized to the inferior treatment modality will be offered the superior treatment at no cost.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Fractionated 1,540nm Nonablative Laser and Microneedling in the Treatment of Atrophic Acne Scarring in Skin of Color: A Randomized Controlled Study
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: Microneedling
Participants in this arm will receive 5 treatments of microneedling.
Device: Microneedling
The exact microneedling settings will be tailored to each patient based on skin type, photodamage, skin thickness based on area of the face. Settings will be adjusted to deliver similar endpoints among all patients. Each participant will receive 5 treatments a month apart.
Other Name: DermaPen 3MD

Active Comparator: Fractional non-ablative 1,540nm laser
Participants in this arm will receive 5 treatments of fractional non-ablative1,540nm laser.
Device: Fractional non-ablative 1,540nm laser
The exact laser settings will be tailored to each patient based on skin type, photodamage, skin thickness based on area of the face. Settings will be adjusted to deliver similar endpoints among all patients. Each participant will receive 5 treatments a month apart.
Other Name: Palomar StarLux




Primary Outcome Measures :
  1. Change in the Goodman and Baron score [ Time Frame: Before treatment starts and 3 months after the last/5th treatment ]
    The Goodman and Baron score considers type of scar, number of scars, and severity of scarring and assigns a grade 1-4 with grade 1 representing mild, macular disease and grade 4 representing severe scarring that is obviously visible at social distances of 50cm, is not easily covered by makeup, and is not able to be flattened by manual stretching of the skin. Lower scores are favorable.


Secondary Outcome Measures :
  1. Treatment satisfaction [ Time Frame: 3 months after the last/5th treatment ]
    A questionnaire with questions about participant satisfaction with the treatment, perceived improvement, and perceived adverse effects will be administered at the last visit, 3 months after the treatment is complete. Responses will be compared between the two treatment arms.

  2. Impact of skin disease on the quality of life [ Time Frame: 3 months after the last/5th treatment ]
    Impact of skin disease on the quality of life will be assessed using the Dermatology life Quality Index (DLQI) which is a ten-question questionnaire with responses options of: Very much=3, A lot=2, A little=1, Not at all=0, or Not relevant=0. Range of scores are from 0 to 30 and interpreted as: 0 - 1= no effect at all on patient's life, 2 - 5= small effect on patient's life, 6 - 10= moderate effect on patient's life, 11 - 20= very large effect on patient's life, and 21 - 30= extremely large effect on patient's life. Responses will be compared between the two treatment arms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred to dermatology clinic for any reason, or resident or attending dermatologists at Boston University.
  • Individuals (men and women) aged 18 and older
  • Patients must have atrophic facial acne scarring on the face and desire treatment to improve appearance of acne scarring
  • Patients must have Fitzpatrick skin type III-VI
  • Patients must be willing to receive five acne scarring treatments at monthly intervals with one follow-up visit to assess for efficacy and adverse effects
  • Subjects must speak either English, Chinese, or Spanish.

Exclusion Criteria:

  • Subjects who are unable or unwilling to give informed consent.
  • Personal history of photosensitivity or photosensitive diseases.
  • Pregnancy or breast-feeding.
  • Facial surgical or laser treatment in the last 3 months.
  • Patients with any active skin infection in the treatment area.
  • Coagulopathies or anticoagulant therapy.
  • Personal history or presence of hypertrophic scars or keloids.

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): NCT03395678


Contacts
Contact: Hye Jin Chung, MD, MMS 617-638-7420 HyeJin.Chung@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Hye Jin Chung, MD MMS    617-638-7420    HyeJin.Chung@bmc.org   
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Hye Jin Chung, MD, MMS Boston University Department of Dermatology

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT03395678     History of Changes
Other Study ID Numbers: H-37256
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Boston University:
Microneedling
Nonablative fractional lasers
Fitzpatrick skin types III-V
Arophic acne scarring

Additional relevant MeSH terms:
Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes