Acne Scarring in Skin of Color: Laser vs Microneedling

November 11, 2019 updated by: Boston University

Comparison of Fractionated 1,540nm Nonablative Laser and Microneedling in the Treatment of Atrophic Acne Scarring in Skin of Color: A Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Palomar StarLux

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Before treatment starts and 3 months after the last/5th treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 months after the last/5th treatment
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.
3 months after the last/5th treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hye Jin Chung, MD, MMS, Boston University Department of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-37256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

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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