CST brings you today's FDA Hearings on dermal fillers.
Don't miss our blog in "real time" from today's FDA Plastic and Reconstructive Devices Advisory Panel.
Procedure Description: Injectable fillers and “volumizers” are used to plump up thin, skeletal hands, either with injections of fat harvested from the patient’s own stomach, thighs, or buttocks or with a cosmetic dermal filler, such as Restylane or Perlane. Both fillers are made from non-animal sourced hyaluronic acid and have been approved by the FDA for the correction of facial folds and wrinkles (dermal fillers for the hands remain an off-label use). Another volumizing option is poly-L-lactic acid (marketed in the U.S. as Sculptra), a synthetic polymer that has been widely used in dissolvable stitches, bone screws and facial implants. A collagen stimulator as opposed to a filler, Sculptra has been approved by the FDA to restore and correct facial fat loss in people with HIV (again, use on the hands is off-label).
Length of Procedure: Varies
Recovery: Side effects can usually be managed with ice packs and acetaminophen. It takes about two weeks for the swelling to go completely down and for the effects to be most noticeable.
Risks: Patients may have a little bruising and discomfort.
Results: Restylane and Perlane last about six to eight months, Radiesse lasts about a year, Sculptra sticks around for about one year and fat injections can last anywhere from two to five years. While fat injections may last longer, fat can re-absorb so this approach often requires additional sessions.
Estimated Cost: Cost for soft tissue fillers can run from $500 to $3,000 and fat injections can cost $1,200 to $5,000, depending on where a patient lives and the number of treatments required.
Procedure description: Tummy tucks, or abdominoplasty, can help reduce the appearance of loose, fat and flabby skin around the abdomen by tightening stomach muscles and strengthening the abdominal walls. The surgery removes diet- and exercise-resistant fat and tightens sagging skin that has lost its elasticity.
Length of procedure: The tummy tuck generally takes about 2 to 4 hours, depending on the extent of the repair. A partial abdominoplasty takes about 1 or 2 hours. Candidates for the partial procedure are patients whose excess skin and abdominal fat is, for the most part, below the belly button. The incisions for partial abdominoplasty are sometimes shorter.
Recovery: This procedure is most often outpatient and therefore patients return home the same day to begin their recovery. After surgery, patients experience swelling, (which can last a few weeks) pain, and discomfort (which will last for the first few days and can be combated with medication). There is usually little or no bruising; however, numbness may persist as long as 12 months. Mild exercise such as walking and appropriate diet can shorten the recovery time and help the body heal more quickly. After about 3 days, you may begin light activities. At this point, the post-surgical gauze dressing may be replaced by a new abdominal supporter. Down time from work can range from 3 to 4 days to 2 weeks or more. Your scars may appear to worsen during the first few months, but this is normal. It may take up to 18 months before your scars flatten out and lighten in color.
Risks: As with any major surgery, the possibility of infection and an adverse reaction to the anesthetic are always present. The most common complications associated with this procedure include infection, bleeding and scarring. Other, less common complications include skin death; hematoma (collection of blood), seroma (fluid buildup); skin stretch-back, or a mild recurrence of skin laxity; belly button death; excessive scarring; excessive bleeding; DVT (deep venous thrombosis) and ruptured stitches. Tummy tucks result in extensive scarring, and patients should talk with their surgeons about this side effect before going ahead with the procedure. Smokers tend to be at a 10-fold increased risk for side effects from surgery, especially procedures such as a tummy tuck.
Results: As long as you keep your weight relatively constant, eat a healthy diet, exercise regularly and follow your surgeon’s instructions about how and when to resume physical activity, the long-term results from a tummy tuck are generally excellent.
Unless you gain or lose a significant amount of weight or become pregnant, your abdomen should remain firmer and flatter for many years. However, gravity and the effects of aging will eventually take their toll. If, after a period of years, you again become dissatisfied with the appearance of your abdomen, you may choose to undergo a second procedure to restore a more youthful body contour.
Estimated cost: Price will range between $6,000 and $10,000 when anesthesia and facility fees are included.
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Researchers at the University of Michigan have found that photodynamic therapy using topical 5-aminolevulinic acid (5-ALA) and pulsed-dye laser treatment produces statistically significant quantitative cutaneous molecular changes—specifically the production of type I and III collagen. These changes are associated with an improvement in the skin's appearance.
The damaging effects of ultraviolet irradiation to the skin are well known. In recent years, several visible and infrared light sources and lasers have been found to improve the clinical and histologic appearance of the skin, and using a photosensitizing compound to enhance the effects of these therapies has been advocated.
Jeffrey S. Orringer, M.D., clinical assistant professor, Department of Dermatology, University of Michigan, Ann Arbor, and his colleagues conducted the study "to quantitatively examine the epidermal and dermal cellular and molecular changes that occur after photodynamic therapy of photodamaged human skin."ENHANCED TREATMENT
The study included 25 patients between the ages of 54 and 83 years who had clinically evident photodamage on the skin of their forearms that was rated by investigators as "at least moderate in severity." Fifteen patients were women and 10 were men.
Exclusion criteria included the following:
In these study participants, 5-ALA was applied for three hours. Treated areas measured approximately 2.5 cm x 8.0 cm. After the treatment site was washed with Cetaphil cleanser, pulsed-dye laser therapy was applied to focal areas of patients' photodamaged forearms using non-purpura-inducing settings: 595-nm wavelength, 10-mm spot size, 10-ms pulse duration and a fluence of 7.5 J/cm2 . After laser therapy, the treatment site was washed with Cetaphil cleanser and covered with a bandage.
To evaluate the changes, biopsy specimens were obtained at baseline, and patients were re-evaluated and provided additional skin biopsy samples four to five times during the first six months after treatment. Twenty-four of the patients provided at least four skin biopsy samples. One patient developed contact dermatitis from the adhesive in the bandage placed after treatment and was excluded from the study.
EVALUATING CHANGE
The researchers used immunohistochemical analysis to assess patients' levels of epidermal proliferation (Ki67), epidermal injury (cytokeratin 16) and photodamage (p53). They also assessed markers of dermal collagen production, which included prolyl 4-hydroxylase, heat shock protein 47 and type I procollagen. To assess the amount of type I and type III collagen, real-time reverse transcriptase-polymerase chain reaction technology was used. Enzyme-linked immunosorbent assay was used to assess the amount of type I procollagen protein.
This treatment resulted in a 5-fold increase in Ki67 and a 1.4-fold increase in epidermal thickness. Additionally, the treatment produced epidermal injury, which was demonstrated by cytokeratin 16 levels that were 70-fold higher after treatment compared with baseline levels.
The researchers also observed upregulation of collagen production, which was demonstrated with 2.65-fold increases in procollagen I messenger RNA, 3.32-fold increases in procollagen III messenger RNA, and 2.42-fold increases in procollagen I protein levels.
"The baseline epidermal p53 level correlated with cytokeratin 16 levels at acute time points, and the latter were found to correlate with peak collagen production," the researchers report.
In other words, patients' dermal responses to this therapy regimen may be predicted by baseline epidermal p53 immunostaining levels. The investigators compared their results with historical data using pulsed-dye laser therapy alone, and they found that the use of the photosensitive compound in conjunction with laser therapy may provide more beneficial changes in the skin.
OTHER LIGHT SOURCES
The results of this study suggest that using a photosensitive compound may enhance the results obtained with other light sources. "For physicians already using visible light sources, such as IPL and some lasers, the findings of this study suggest that clinical results in terms of photorejuvenation might be enhanced by including the use of a topical photosensitizer (like Levulan [20% 5-ALA solution]) in the treatment regimen. The results of this study are specific to the topical photosensitizer (5-ALA) and light source (pulsed-dye laser) used. However, there is reason to believe that other light sources such as IPL devices might produce similar or even more profound molecular and clinical changes," Dr. Orringer says. He notes that this study was a "proof in principles" protocol in some respects because it examined the molecular effects of photodynamic therapy using a fairly long photosensitizer application time. Further studies are needed to determine whether shorter application times of the photosensitive compound would produce similar changes in the skin. "The study is an attempt to quantify the molecular and cellular changes brought about in the skin by a specific photodynamic therapy regimen. Several key findings provide evidence for the validity of this clinical treatment approach, including evidence of substantial dermal remodeling, collagen production, and epidermal thickening that result from photodynamic therapy. These results are part of an evolving molecular model that we believe will one day help predict the clinical value of new cosmetic interventions. We believe that the quantitative amount of dermal repair and regeneration induced by a specific treatment likely underlies the degree of clinical rejuvenation produced," he concludes.
Reference
Orringer JS, Hammerberg C, Hamilton T, et al. Molecular effects of photodynamic therapy for photoaging. Arch Dermatol. 2008;144:1296-1302.
For more information
Jeffrey S. Orringer, M.D.
jorringe@umich.edu
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Miller School Dean Pascal J. Goldschmidt, M.D., formerly of Duke University, came up with the idea, she says.
CUTTING THROUGH RED TAPE
By combining the specialties and formalizing the institute, Dr. Baumann and colleagues can cut research red tape.
According to Dr. Baumann, "The way a university works, everybody has to report to their own different chairmen, so it gets very complicated with research. When you write a research protocol, all these different chairmen would have to sign off on it. Now, we are our own institute, so I am the only one that has to sign off. ...it allows all of us to work together in an academic setting, which is difficult to do if you are in different departments."
RESEARCH INITIATIVES
UM has long been conducting skin cream, dermal filler, botulinum toxin and laser and light research trials and will continue those. Dr. Baumann and colleagues conducted phase 3 trials that led to the approval of Botox in 2002. Their research also helped to lead to approvals for Hylaform, Hylaform Plus, Juvéderm Ultra and Juvéderm Ultra Plus.
"We are currently involved in the Reloxin and Sculptra trials, including 20 other trials that I cannot talk about," Dr. Baumann says.
But the new institute has also begun surgery-based, genetic and stem cell trials. The main goal of the Institute, according to Dr. Baumann, is to find the genes associated with the 16 Baumann Skin Types she identifies in her book, The Skin Type Solution.
CMRI staff will gather the data this way: Each patient that has cosmetic surgery by one of CMRI's surgeons fills out the Baumann Skin Type Indicator questionnaire. The results of this questionnaire and the discarded skin from the surgery will be banked in a skin repository, or skin bank. The researchers will then conduct genetic studies using the skin to look for patterns of gene expression.
The system will not only result in banked skin, but also important existing data on that skin, she explains. The questionnaire asks questions about acne, rosacea, dry skin, oily skin, smoking, use of tanning beds, estrogen therapy and much more.
"We will have very specific medical and skin history data banked with the skin. If a company, then, comes to me and says it wants to do a study on this new rosacea drug...we can pull from the bank and use it for our research," Dr. Baumann says.
CMRI researchers are also teaming up with geneticists from UM's new Miami Institute for Human Genomics, which is led by Drs. Peggy Pericak-Vance and Jeffrey Vance, the husband and wife team, formerly at Duke University, who discovered genetic links to the origins of more than 50 diseases, including Alzheimer's, autism, Parkinson's, multiple sclerosis and tuberculosis.
"The other main [CMRI] research initiative is to bank skin cells derived from discarded liposuction fat. Fat is a huge source of stem cells," Dr. Baumann says. "Our surgeons will donate the extracted fat cells to grow stem cells and research the role that stem cells play in aging."
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VALIDATING VOLUME
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 Figure 1. Oblique view of a 60-year-old man with lower eyelid prominence. Photo credit: Sean Darcy, M.D. |
"In the periorbital area, blepharoplasty surgery traditionally was used to remove 'excess fat.' More recently, our group and others have focused on volume loss in the periorbital area, adding volume with fat grafts, fat injections and synthetic fillers. We hoped, in this study, to provide better understanding of the role of volume changes in the orbital fat. Understanding the anatomic nature of aging changes can help to guide surgical and nonsurgical rejuvenation techniques," adds Robert Goldberg, M.D., chief of orbital and ophthalmic plastic surgery and co-director of the aesthetic reconstructive surgery service at UCLA's Jules Stein Eye Institute, who conducted the study with Dr. Darcy.
The study included 40 people between the ages of 12 and 80. Seventeen were men, and 23 were women. Patients were divided into three groups according to age. Thirteen people (6 men and 7 women) were between the ages of 12 and 29 years. Twelve people (5 men and 7 women) were between the ages of 30 and 54 years, and 15 people (6 men and 9 women) were between the ages of 55 and 80 years.
The orbital anatomy of the study participants was measured with high-resolution orbital MRI. The baseline area of the globe in the study participants between the ages of 12 and 29 years was 456 mm2 , and no significant changes were observed with age (463 mm2 in patients between the ages of 30 and 54 years and 456 mm2 in the patients between the ages of 55 and 80 years).
In contrast, the size of the inferior periocular soft-tissue area anterior to the globe axis increased with age. It measured 99 mm2 in the study participants between the ages of 12 and 29 years, 103 mm2 in those between the ages of 30 and 54 years, and 131 mm2 in those between the ages of 55 and 80 years, which was statistically significant.
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Results announced from a prospective, open label, phase II study (IT-R-007) of two treatments of Isolagen Therapy in multiple facial regions ("full face") for facial wrinkles and creases in approximately 40 subjects reported improvement in the appearance of wrinkles as scored by a high percentage of both study subjects, as well as independent panel evaluators. The same results were reported regarding improvement in skin quality. At six months following the final treatment, 83 percent of subjects reported an improvement in their self-assessed score of the appearance of wrinkles. At the six-month point, the results from the independent panel evaluation of study photographs also showed improvement in the appearance of wrinkles, with the independent panel scoring improvement in over 75 percent of participants.
SKIN SCAFFOLDS
"This current study, conducted at five U.S. sites, is a strong research base that not only covers [Isolagen's impact] on wrinkles, but also skin rejuvenation. This therapy is like introducing scaffolding to the skin —a way to prepare the skin for other treatments," says Declan Daly, president and chief executive officer, Isolagen, Inc. |
COMPLICATIONS AND COST
Complication and expense of harvesting, storing and administering patients' own cells is the primary concern surrounding Isolagen's ultimate success. While taking a biopsy from the behind the ear to create the injection is simple, the overall cost of growing and multiplying the fibroblasts for its final destination causes concern. Isolagen treatment ranged from £2,500 to £5,000 when offered in the UK in 2002, and $4,000 per patient in the U.S. at last estimate (2004).
Yet, if a patient makes the investment upfront with a "full-face treatment," followed by a yearly treatment, the price is probably not going to be much different than receiving filler treatments three times a year, explains Mr. Daly.
"These issues are yet to be determined based on pricing and education of physicians and patients," says David H. McDaniel, M.D., F.A.A.D., director, Institute of Anti-Aging Research, Eastern Virginia Medical School, and assistant professor of Clinical Dermatology and Plastic Surgery, Eastern Virginia Medical School, Virginia Beach, Va. "The biopsy process is very simple and safe, and over the long term Isolagen will likely prove to be very cost effective because of it duration of benefits."
As for its "competition," both Mr. Daly and Dr. McDaniel agree that Isolagen should not be considered a competitor to fillers, but rather a nonsurgical alternative to peels and laser procedures.
"Fillers are primarily volumizers, whereas I view Isolagen more as 'replacement therapy.' That is, Isolagen is restoring or augmenting what was either lost or damaged from aging," says Dr. McDaniel, who is also co-director, Skin of Color Research Institute, Hampton University. "It may be competitive for some of the very fine-line fillers that have a short-lived effect, but predominantly this is a new tool for the cosmetic surgeon to add to his or her menu of therapies."
Using a 29-gauge needle, proper administration of Isolagen is technique sensitive, and training will be vital as it differs from administering injectable fillers, according to Dr. McDaniel. "However, this is simple to train and the biopsies are very easy — I do not foresee a significant problem overall."
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Procedure description: Breast reduction, also called reduction mammaplasty, is most often done in the hospital or surgicenter, under general anesthetic. The most commonly made incision encircles the areola (darkened area around the nipple) and extends downward and around the underside of the breast. This produces the least conspicuous scar. The excess tissue, fat, and skin are removed, and the nipple and areola are repositioned. In certain cases, liposuction is used to remove extra fat from the armpit area. In most cases, the nipples remain attached to their blood vessels and nerves. However, if the breasts are very large or pendulous, the nipples and areolas may have to be completely removed and grafted into a higher position as a skin graft. (This ultimately results in loss of function of the nipple including; sensation, erection and the ability to breast feed).
Length of Procedure: Breast reduction surgery generally takes about 1 to 3 hours per breast, depending on extent of the repair and the techniques being used.
Recovery: Your breasts will be wrapped with gauze bandage, plus a tighter bandage for protection and support. You also may have small drainage tubes coming out of the incisions to help drain some of the excess fluid. Your bandages will be removed after a day or two, and you will continue wearing a surgical bra, around the clock, for several weeks, until the swelling and bruising subside. The stitches will be removed in 1 to 3 weeks.
Light activities can be resumed within a few days; although, your chest will be sore. You may also be instructed to avoid sex for a week or more, since sexual arousal can cause your incisions to swell. Routine physical activity and exercising (especially lifting, pulling and pushing motions) should be avoided for at least 6 weeks.
Risks: The most common complications associated with this procedure include infection, bleeding, and scarring. Other, less common complications include skin death; hematoma (collection of blood), seroma (fluid buildup). In this surgery, serious complications are quite rare, but there is a chance for significant blood loss due to the magnitude of the surgery. In addition, small areas of infection or delayed healing in the incisions is not uncommon. There is also a possibility of developing small sores around the nipples, which can be treated with antibiotic creams. Some patients may experience a permanent loss of feeling in their nipples or breasts.
Results: Smaller breast size should be achieved, and with that, less neck, back and shoulder pain. The breasts will remain smaller than they would have been if surgery had not been performed. Unfortunately, gravity continues to work, and the breasts will sag again with time. Your surgeon will make the incisions as inconspicuous as possible, but the scarring from this surgery is fairly extensive and permanent. These scars are long, and they remain pink or brown for several years.
Estimated Cost: Because large breasts can be hereditary, the procedure is quite often covered by insurance, if certain criteria are met. These criteria would have to be discussed with your doctor before submitting them to your health insurance carrier. The average breast reduction cost varies from $5,000 to $7,000. Fees include anesthesia, which ranges from $1,000 to $1,500, and the facility fee (or hospital fee), which ranges from $500 to $2,000. The remaining cost will be the surgeon's fee.
Procedure Description: NOTE: This procedure is outdated and better skin resurfacing options exist. Through controlled surgical “sanding” of damaged skin, dermabrasion allows smoother, younger-looking skin to form. The doctor will begin the procedure by covering your eyes and hair. Next, he/she will numb your skin, perhaps by injecting anesthesia or by spraying your skin with a refrigerant. Before spraying the skin, the doctor may apply a cold pack to numb the area. You may also be given a sedative. Dermabrasion consists of a measured scraping of damaged skin from the face to create an area where a new layer of skin may form. To remove the skin, the doctor uses a handheld, motorized instrument, often with a brush, or sanding wheel, containing diamond particles, which touch the skin.
Length of Procedure: Dermabrasion is a fairly quick procedure. The time that it takes depends on the size and the condition of the area to be treated. Usually, it is completed in 30 to 60 minutes.
Recovery: After the dermabrasion procedure, the treated area may be covered with an ointment, a wet or waxy covering and/or a dry covering. For a few days after the procedure, the skin looks and feels as if it has been scraped (such as in a fall). A scab will form over the treated area within 24 to 48 hours after the procedure. After several days, the outer layer of skin, including any scabbing, begins to loosen and fall off. Once this layer is gone, the skin is very pink, but that pinkness fades at about three to six weeks. During this time, special soaps and cosmetics may be applied to the area. It may be possible to perform your work duties within the first two days, although your skin may still be red and sore. Most people return to work in about two weeks, giving the skin a chance to heal.
Risks: Infection and scarring are rare, but can occur. If too much scar tissue forms, it may be softened with steroid injections. Occasionally hyperpigmentation (darkening of the skin) occurs, but this may be treated with bleaching cream. Skin lightening or patchiness can also occur, especially on people with darker natural skin tones. After the procedure, some patients get small whiteheads called milia. These usually disappear after washing, but some may require the doctor’s help to remove them.
Results: Dermabrasion can produce dramatic results. The outcome depends on the original condition of the skin, skin tone, the depth of wrinkles and other imperfections, as well as individual healing ability. Normal results include significant improvement in the appearance of the skin's surface after healing of the skin.
Estimated Cost: The average cost of dermabrasion is $1,367.
