SkinPen Efficacy on Acne Scars on the Face and/or Back
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|ClinicalTrials.gov Identifier: NCT02646917|
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : October 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrophic Acne Scar||Device: SkinPen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Center Trial to Evaluate the Efficacy and Tolerability of SkinPen on Male and Female Subjects' Acne Scars on the Face and/or Back|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||July 25, 2017|
3 SkinPen treatments to each patient, each one month apart.
Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.
- Assessment of Change of Acne Scar Severity using Goodman and Baron's quantitative and qualitative grading system [ Time Frame: Baseline, 1 month post treatment, and 6 month post treatment ]Assessment of acne scar severity using Goodman and Baron's quantitative and qualitative grading system at baseline, 1 month post treatment and 6 months post treatment.
- Assessment of Change of Facial Wrinkling using a modified Griffiths' 10-point scale [ Time Frame: Baseline, 1 month post treatment, and 6 month post treatment ]Assessment of facial wrinkling at baseline, 1-month post treatment, and 6-months post treatment using a modified Griffiths' 10-point scale
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): NCT02646917
|United States, Texas|
|Stephens & Associates|
|Richardson, Texas, United States, 45081|
|Principal Investigator:||Thomas J Stephens, Ph.D||Thomas J. Stephens & Associates, Inc.|