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Acne Scarring in Skin of Color: Laser vs Microneedling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395678
Recruitment Status : Withdrawn (Sample size can not be obtained at this site.)
First Posted : January 10, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Boston University

Tracking Information
First Submitted Date  ICMJE January 4, 2018
First Posted Date  ICMJE January 10, 2018
Last Update Posted Date November 13, 2019
Estimated Study Start Date  ICMJE November 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acne Scarring in Skin of Color: Laser vs Microneedling
Official Title  ICMJE Comparison of Fractionated 1,540nm Nonablative Laser and Microneedling in the Treatment of Atrophic Acne Scarring in Skin of Color: A Randomized Controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acne Vulgaris
  • Scar
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Microneedling
    Participants in this arm will receive 5 treatments of microneedling.
    Intervention: Device: Microneedling
  • Active Comparator: Fractional non-ablative 1,540nm laser
    Participants in this arm will receive 5 treatments of fractional non-ablative1,540nm laser.
    Intervention: Device: Fractional non-ablative 1,540nm laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 11, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2018)
30
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03395678
Other Study ID Numbers  ICMJE H-37256
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston University
Study Sponsor  ICMJE Boston University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hye Jin Chung, MD, MMS Boston University Department of Dermatology
PRS Account Boston University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP