Are there other dermal fillers on the market with FDA approval to treat acne scars?
No, Bellafill® is the only FDA-approved dermal filler, on the market, for the correction of atrophic (pitted), distensible facial acne scars on the cheek. No other dermal filler on the market is approved for the treatment of acne scars.
What is Bellafill®‘s indication for use?
Bellafill® is the only dermal filler FDA approved for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years. It is also the only dermal filler established safe and effective for nasolabial fold correction through 5 years.
How long does Bellafill® last?
Satisfaction and effectiveness for the correction of nasolabial folds have been established through 5 years. Effectiveness for the correction of acne scars has been proven through 12 months.
Is there a current demand for effective acne scar treatments?
Yes. Millions of Americans suffer from acne and billions of dollars are spent each year on treatments. Furthermore, a significant number of acne sufferers go on to develop devastating scarring. Physician and patient market research shows relatively low satisfaction with many available treatments with patients having to make trade-offs between efficacy, longevity, safety, downtime, and cost. Now with Bellafill®, acne scar sufferers have a new treatment choice that is proven to be safe and effective with minimal to no downtime.
What is the physical and emotional impact of acne scars?
Acne is the most common skin disorder in the U.S., affecting up to 40–50 million Americans. A significant number of acne sufferers go on to develop devastating scarring. Physician and patient market research shows relatively low satisfaction with many treatments, and patients having to make trade-offs between efficacy, longevity, safety, downtime, and cost.
Scars are more than skin deep, and have been shown to cause high levels of anxiety and self-consciousness. In an independent study 92% of people said if their acne scars were healed, it would restore or improve their self-confidence.
Now with Bellafill®, acne scar sufferers have a new treatment choice, approved by the FDA, that is proven to be safe and effective with minimal to no downtime.
What is the difference between Bellafill® and ArteFill®?
Bellafill® is the new name for ArteFill® in North America. It is distributed under the trade name ArteFill® in South Korea and Singapore. ArteFill® was rebranded to Bellafill® in the U.S. to reflect the transformational outcomes this unique product can provide to patients seeking correction of their acne scars and nasolabial folds. In markets outside of the U.S., the product is only approved for nasolabial folds.
What kind of research has been done to determine acne scar effectiveness?
A pivotal, randomized, double-blinded, placebo-controlled study was conducted to evaluate the effectiveness and safety of Bellafill® for treating moderate to severe, atrophic, distensible facial acne scars on the cheek. Subjects were randomized to Bellafill® vs. saline injections. Bellafill® was found to be a safe and effective treatment when compared to control treated subjects.
This study maintained a high threshold for success: the primary effectiveness endpoint defined a responder as a subject who had 50 percent or more of treated acne scars, improve by two or more points on a validated 4-point Acne Scar Rating Scale (ASRS). This six month endpoint was met with statistical significance and, as a secondary endpoint, continued to show improvement at nine and 12 months when assessed by the un-blinded investigator. Subjects blinded to treatment also reported successful outcomes and demonstrated improvement in their global appearance after treatment with Bellafill®.
When did Bellafill® receive FDA approval for the treatment of acne scars?
Bellafill® received FDA approval for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years in December 2014.
How long has Bellafill® been available in the U.S.?
Bellafill® was FDA approved in October 2006 (under the name ArteFill®) for treating nasolabial folds (smile lines). In December 2014, Bellafill® was approved by the FDA for the correction of atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.