A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars
|ClinicalTrials.gov Identifier: NCT02643628|
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : October 28, 2019
Last Update Posted : October 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrophic Acne Scars||Procedure: Microneedling Device: Microneedling followed by Bellafill treatment||Not Applicable|
The study is divided into two study Periods. In Period I, subjects will attend a Screening visit (Week -4) and undergo the Bellafill skin test. At Visit 1 (Day 0), all subjects will commence microneedling treatment for their atrophic acne scars. Subjects will then return to the clinic at Week 3 and Week 6 (Visits 2 and 3, respectively) for follow-up evaluation and additional cycles of microneedling treatment.
At Week 12 (Visit 4), all subjects commence Period II and are randomized to Bellafill Treatment (Track A) or to No Treatment (Track B):
- Track A: Consists of three (3) study visits. At Visit 4, subjects randomized to the "Bellafill" group will receive treatment with Bellafill for their atrophic acne scars. Subjects return for Visit 5A (Month 1 after randomization) for evaluation and follow-up, and will receive touch-up injections with Bellafill to achieve optimal correction (if necessary). Subjects will then be followed-up at Visits 6A and 7A which will occur at Month 3 and Month 6, respectively, after their last Bellafill treatment.
- Track B: Consists of one (1) study visit. At Visit 4, subjects randomized to the "No Treatment" group will complete visit evaluations and then return for follow-up at Visit 5B (approx. Month 3 after randomization).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars|
|Actual Study Start Date :||October 10, 2015|
|Actual Primary Completion Date :||June 5, 2017|
|Actual Study Completion Date :||June 5, 2017|
Experimental: Microneedling Only
All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction.
Experimental: Microneedling followed by Bellafill treatment
Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction.
Device: Microneedling followed by Bellafill treatment
- Acne Scar Assessment Scale (ASAS) [ Time Frame: 6 months post-injection for Bellafill arm. 3 months Microneedling alone arm ]• Acne Scar Assessment Scale (ASAS): a validated 5-point static scale assessing physician impression of acne scar severity where as 1=clear and 5 = severe
- Physician Global Aesthetic Improvement Scale (PGAIS) [ Time Frame: From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm ]The PGAIS is used for the physician to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse
- Subject Global Aesthetic Improvement Scale (SGAIS) [ Time Frame: From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm ]The SGAIS is used for the subject to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse
- Quality of Life Impact Scar (QOLIS) [ Time Frame: 6-months for the Treatment arm and 3 months for the Microneedling only arm ]Quality of Life Scar Impact Scale questionnaire was used to allow the subject to specifically address how acne scarring has affected his/her emotional and functional status. Subjects completed 33 questions ratings between 1 and 7 one being less severe 4 neutral and 7 more severe. Scores are averaged for a total range of 1-7.
- Number of Subjects With Adverse Events [ Time Frame: 6-months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643628
|United States, Tennessee|
|Call Suneva for Info|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Nancy Seretta||Suneva Medical|