NCT02643628

A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Suneva Medical, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, multicenter, prospective trial assessing the efficacy and safety of microneedling treatment alone vs. microneedling treatment followed by treatment with Bellafill for correction of distensible atrophic facial acne scars.

Detailed description

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).

Conditions

• Atrophic Acne Scars

Interventions

Type	Name	Description
PROCEDURE	Microneedling
DEVICE	Microneedling followed by Bellafill treatment

Timeline

• Start date: 2015-10-10
• Primary completion: 2017-06-05
• Completion: 2017-06-05
• First posted: 2015-12-31
• Last updated: 2019-10-28
• Results posted: 2019-10-28

Locations

1 site across 1 country: United States