Acne Scarring in Skin of Color: Laser vs Microneedling
Comparison of Fractionated 1,540nm Nonablative Laser and Microneedling in the Treatment of Atrophic Acne Scarring in Skin of Color: A Randomized Controlled Study
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Primary Completion
December 2020
Estimated (date passed)
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Study Completion
December 2020
Estimated (date passed)
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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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
withdrawn
Actual enrollment (reported)
0 participants
Study completion date
December 2020
Estimated (date passed)
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Listed locations
1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
January 4, 2018
Actual (reported)
First Posted
January 10, 2018
Actual (reported)
Study Start
November 2019
Estimated (date passed)
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Primary Completion
December 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 Outcomes (2)
Treatment satisfaction
3 months after the last/5th treatment
Impact of skin disease on the quality of life
3 months after the last/5th treatment
Study Arms (2)
Microneedling
EXPERIMENTAL
Participants in this arm will receive 5 treatments of microneedling.
Device: Microneedling
Fractional non-ablative 1,540nm laser
ACTIVE COMPARATOR
Participants in this arm will receive 5 treatments of fractional non-ablative1,540nm laser.
Device: Fractional non-ablative 1,540nm laser
Interventions
MicroneedlingDevice
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.
Also known as: DermaPen 3MD
Microneedling
Fractional non-ablative 1,540nm laserDevice
Eligibility Criteria
Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
You may qualify if:
Patients referred to dermatology clinic for any reason, or resident or attending dermatologists at Boston University.
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.
Also known as: Palomar StarLux
Fractional non-ablative 1,540nm laser
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
You may not qualify if:
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.
Contact the study team to confirm eligibility.
Therapeutics
Physical Therapy Modalities
Punctures
Rehabilitation
Optical Devices
Equipment and Supplies
Radiation Equipment and Supplies
Primary Completion
December 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 13, 2019
Record last verified: 2019-11
Data Sharing
IPD Sharing
Will not share
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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