At a glance
ClinicalIndex Comparison RecordN/ACompleted· 45 enrolled
Drug / intervention
Microneedling +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 5
- ✓Age 21 or older
- ✓Negative Bellafill skin test result
- ✓≥4 distensible atrophic acne scars in facial treatment area and desire correction
- ✓All Fitzpatrick skin types eligible
Key exclusion· 8
- ✕Pregnant, breastfeeding, or childbearing potential without reliable contraception
- ✕Facial excisional surgery (blepharoplasty, facelift, rhinoplasty) ≤6 months prior or planned during study
- ✕History of bleeding disorders
- ✕Active skin pathology, infection, cancer/precancer, unhealed wound, or ≥3 active inflammatory acne lesions in treatment area
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne Scars
In Brief
A clinical study evaluating Microneedling and Microneedling followed by Bellafill treatment for Atrophic Acne Scars. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrophic Acne Scars
CountriesUnited States
Collaboratorsethica Clinical Research Inc.
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedDec 2015
Primary CompletionJun 2017
TodayJul 2026
First PostedDec 31, 2015
Enrollment StartOct 10, 2015
Primary CompletionJun 5, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.5 years ago
Interventions
Microneedlingprocedure
Microneedling followed by Bellafill treatmentdevice