Back to resultsAcne Scarring in Skin of Color: Laser vs Microneedling
Primary Purpose
Acne Vulgaris, Scar
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microneedling
Fractional non-ablative 1,540nm laser
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Microneedling, Nonablative fractional lasers, Fitzpatrick skin types III-V, Arophic acne scarring
Eligibility 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.
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Microneedling
Fractional non-ablative 1,540nm laser
Arm Description
Participants in this arm will receive 5 treatments of microneedling.
Participants in this arm will receive 5 treatments of fractional non-ablative1,540nm laser.
Outcomes
Primary Outcome Measures
Change in the Goodman and Baron score
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
Treatment satisfaction
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.
Impact of skin disease on the quality of life
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03395678
Brief Title
Acne Scarring in Skin of Color: Laser vs Microneedling
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Sample size can not be obtained at this site.
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Scar
Keywords
Microneedling, Nonablative fractional lasers, Fitzpatrick skin types III-V, Arophic acne scarring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microneedling
Arm Type
Experimental
Arm Description
Participants in this arm will receive 5 treatments of microneedling.
Arm Title
Fractional non-ablative 1,540nm laser
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive 5 treatments of fractional non-ablative1,540nm laser.
Intervention Type
Device
Intervention Name(s)
Microneedling
Other Intervention Name(s)
DermaPen 3MD
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fractional non-ablative 1,540nm laser
Other Intervention Name(s)
Palomar StarLux
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Goodman and Baron score
Description
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.
Time Frame
Before treatment starts and 3 months after the last/5th treatment
Secondary Outcome Measure Information:
Title
Treatment satisfaction
Description
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.
Time Frame
3 months after the last/5th treatment
Title
Impact of skin disease on the quality of life
Description
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.
Time Frame
3 months after the last/5th treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hye Jin Chung, MD, MMS
Organizational Affiliation
Boston University Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acne Scarring in Skin of Color: Laser vs Microneedling
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