Vollure for the Correction of Atrophic Facial Scarring (NCT04519515)
Double Blind Split Face Randomized Placebo Controlled Clinical Trial Investigating Juvederm Vollure for the Correction of Atrophic Facial Scarring
🩺 Plain-English Summary (8th-Grade Level)
Subjects will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated. Subjects will return 24-48 hours after their first treatment to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary and also return 30 and 90 days after their last treatment to fill out questionnaires, take pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for long-term adverse events by blinded evaluators. At 12 months, 18 months, and 24 months, the subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded evaluators for long-term efficacy.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (22 items).
Location: Siperstein Dermatology Group — Boynton Beach, Florida
Age range: 22 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Subjects with allergies to hyaluronic acid filler, gram positive bacteria or lidocaine.
- Subjects with auto-immune conditions
- Subjects with diabetes
- Subjects with a history of sever anaphylactic reactions
- Subjects with cancer, or other life-threatening medical condition
- Subjects taking anti---coagulants, chemotherapy, immunosuppressive agents, immunomodulatory agents, diuretics, anti---histamines, or anti---inflammatory medications in the 2 weeks prior to the study or who will need to take these medications at any time during the first 120 days of the study.
- Subjects with any scheduled laser, light, or surgical procedures during the study, including dental surgery.
- Subjects who had neuromodulators in the past 6 months or hyaluronic acid fillers in the previous year on the face
- Subjects who at any time had surgery or more permanent fillers in the face such as Bellafill or Radiesse
- Subjects with tattoos or many skin growths on the face that would obscure visualization of the scars
- Subjects with a history of keloid or hypertrophic scar on the face
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Siperstein Dermatology Group — Boynton Beach, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Atrophic Scar clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.