JUVEDERM THE MIRACLE FACIAL WRINKLE FILLER - Hyaluronic Acid What?
Wednesday, October 7th, 2009DR MICHELE KOO, MD, FACS, BOARD CERTIFIED PLASTIC SURGEON, ST LOUIS, MISSOURI wants you to know that JUVEDERM and BOTOX are an extremely safe, economical way with no down time to soften your face in a significant way by smoothing and filling in the facial wrinkles that make you look tired and older than you are. Why always be asked if you are mad or tired? Take charge of your life and in 30 minutes in Dr Koo’s office rejuvenate your face with JUVEDERM AND BOTOX to lift up the frowns around your mouth, ever so subtlely plump your lips, and fill in those deep nasolabial folds.
Dr Koo wants you to know that JUVEDERM AND BOTOX are extremely safe and has been FDA approved for facial use to fill creases and smooth the dynamic lines of your face around the eyes and forehead.
The following is a continuation of an article by Dr Mary Lupo, published in the Plastic & Reconstructive Journal, January 2008. Dr Koo hopes that this is helpful information to let you understand the fillers that are available and to realize that the fillers are very safe.
One small open-label study in France treated 49 subjects with Juvéderm 30 in either one or two of four possible injection sites, the nasolabial folds (59 percent), upper lip (37 percent), glabella (16 percent), and bitterness folds (10 percent).4 Most subjects had a touch-up at 1 to 2 months after treatment, with a mean of 0.6 ml administered at each session. Wrinkle severity improvement of approximately 50 percent on a five-point scale remained stable up to 11 months after initial treatment.
Interestingly, in our study, the nasolabial folds initially treated with Zyplast returned almost to baseline after the initial 24-week period, but subsequent treatment with Juvéderm Ultra Plus resulted in the same duration of clinically significant improvement as seen in the nasolabial folds originally treated with Juvéderm Ultra Plus.
The most significant finding from our studies is the extended duration of correction for Juvéderm Ultra Plus, in particular, for severe folds. Other resorbable fillers (collagens and hyaluronic acids) have not been proven to last beyond 6 months. The most comparable product, Perlane, was developed to treat deeper folds in that it is indicated for injection into the deep dermis and has larger hyaluronic acid gel particles than its sister product Restylane, both from Medicis Aesthetics (Scottsdale, Ariz.).5 Juvéderm has a different manufacturing process that creates a homogenous gel without a granular consistency.
In a split-face study comparing Perlane to Zyplast in 68 subjects with a range of different wrinkle severities from mild to extreme, 26 percent were classified as having severe nasolabial folds before treatment, although results were not stratified by baseline nasolabial fold severity.6 At 6 months after optimal correction, 59 percent of all Perlane-treated folds maintained correction, as opposed to the 96 percent noted in the Juvéderm Ultra Plus severe folds study. Moreover, at 9 months, only 49 percent of the Perlane folds were rated as superior to Zyplast, with 37 percent showing equivalency between Perlane and Zyplast and 14 percent showing Zyplast to be superior to Perlane.
Given that Juvéderm Ultra Plus outlasts the temporary dermal fillers, perhaps it should be compared with the semipermanent fillers Radiesse (BioForm Medical, San Mateo, Calif.) and Sculptra (Dermik Aesthetics, Berwyn, Pa.). Radiesse consists of synthetic calcium hydroxylapatite microspheres suspended in a gel of glycerin, water, and sodium carboxymethylcellulose.7 Following injection, the gel dissipates, collagen production is stimulated for volumizing, and phagocytosis gradually breaks down and eliminates the microspheres.
In December of 2006, the U.S. Food and Drug Administration approved Radiesse for correction of moderate to severe facial wrinkles and folds such as nasolabial folds and for facial lipoatrophy in people with human immunodeficiency virus,8 although the product had earlier been approved for other uses such as vocal cord augmentation and was used off-label, particularly for deep creases such as severe nasolabial folds.9 The pivotal trial involved 117 subjects treated with Radiesse in one nasolabial fold and human collagen in the other nasolabial fold with up to two touch-ups allowed at 2-week intervals to attain optimal correction (mean Radiesse injection volume, 1.2 ml).8 Rated on a six-point scale using blinded photographic assessments, the mean improvement in wrinkle severity at 6 months was 1.3 (compared with 1.7 on a five-point scale for Juvéderm Ultra Plus at the same time point), and no long-term data were provided.
In a small open-label study, patient self-reports showed duration of nasolabial fold correction of 10 to 12 months for four of 18 subjects and greater than 12 months for 14 of 18 subjects.10 Another open-label study was based on surveys sent to 609 subjects who had received Radiesse injections to the nasolabial folds or other facial areas.11 Responses to the 6-month survey were received from 155 subjects, and responses to an additional survey sent between 12 and 24 months after initial treatment were received from 112 subjects. Average subject satisfaction at 6 months was 3.9 on a five-point scale (with 5 being most satisfied). In the 12- to 24-month survey, 69 percent reported satisfaction, although the most common comment was thought it would last longer. Importantly, 84 percent of subjects (n = 512) required repeated treatments to achieve or maintain optimal correction. Of those, 63 percent had touch-ups at 4 to 6 weeks and 53 percent at 5 to 9 months.
Sculptra is an injectable poly-L-lactic acid indicated for correction of lipoatrophy though, like Radiesse, it is used off-label for cosmetic wrinkle correction and volumizing. The product must be reconstituted with water at least 2 hours before injection, and the correction fades within 1 week as the fluid is absorbed. The mechanism of action is the stimulation of collagen production, which requires several injections at intervals of at least 2 weeks to generate cosmetic improvement.12 Clinical studies on Sculptra have focused on human immunodeficiency virus-positive subjects with facial lipoatrophy13; thus, the longevity of correction in facial wrinkles is unknown.
One salient point about the semipermanent fillers is that they are generally injected through larger needles than used with collagen or hyaluronic acid-based fillers to prevent the particles in the product from clogging the needle. A 25-gauge needle is preferred for Sculptra,14 and a 25- to 27-gauge needle is recommended for Radiesse,15 with a larger needle having greater propensity to generate tissue trauma and pain on injection. In contrast, Juvéderm Ultra Plus is injected through a smaller 27-gauge needle.2 Moreover, Radiesse and Sculptra are intended for placement only in the deep dermis or dermal-subcutaneous junction and do not have the flexibility to treat finer wrinkles and folds, as can Juvéderm Ultra Plus.
CONCLUSIONS
Juvéderm Ultra Plus represents an excellent combination of attributes for a dermal filler. Permanent products bear some long-term risk if the initial correction is excessive or misapplied and can result in an unnatural appearance as aging tissues shrink and make the filler visible.16 Semipermanent fillers, in contrast, are prone to the problems endemic to the particulate nature of these products, may require larger needle sizes, and have limited utility in superficial defects or wrinkles. Juvéderm Ultra Plus may have found the sweet spot of an ideal duration for wrinkle correction with a good safety profile.
