Acne Scarring in Skin of Color: Laser vs Microneedling
|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Recruitment Status : Withdrawn (Sample size can not be obtained at this site.)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
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris Scar||Device: Microneedling Device: Fractional non-ablative 1,540nm laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||November 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Participants in this arm will receive 5 treatments of 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
- 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.
- 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.
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
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Hye Jin Chung, MD, MMS||Boston University Department of Dermatology|