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Varicose Veins Colorado
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botox TM ®
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JUVÉDERM ™ Injectable Gel is the latest dermal filler advance from Allergan Inc. JUVÉDERM™ Injectable Gel is a "next generation" smooth gel, non-animal dermal filler offering a natural look/feel and long-lasting results for up to six months or longer. JUVÉDERM™ Injectable Gel dermal filler lasts long because it's the only dermal filler currently available with the highest concentration of hyaluronic acid and a special formulation process. This process creates a smooth gel that flows easily into the skin, creating smooth, natural looks.All other currently approved hyaluronic acid dermal fillers use a gel particle suspension formulation. These gel particles can be visibly seen as opposed to the smoother formulation used in JUVÉDERM™ Injectable Gel. The smooth consistency of JUVÉDERM™ Injectable Gel dermal filler also may help to minimize the discomfort that can sometimes occur during the injection procedure.
What is JUVÉDERM™ Injectable Gel ?
Over recent years, hyaluronic acid has emerged as the miracle compound for filling in wrinkles.Hyaluronic acid is a physiological constituent of dermal tissue which maintains local moisture content and is gradually reabsorbed with time. Juvéderm is a hyaluronic acid in the form of viscoelastic gel, which is transparent and homo-geneous and which has four major benefits :
It is obtained by biosynthesis and is of non-animal origin
It does not require any prior test
The molecule is highly biocompatible..
JUVÉDERM™ Injectable Gel is obtained by bacterial fermentation and is part of the new generation of implants, while at the same time enjoying the experience of the Corneal group, in the synthesis of cross-linked hyaluronic acid.
JUVÉDERM™ Injectable Gel is presented in the form of a pre-filled syringe, containing a viscoelastic, transparent hyaluronic acid gel.
JUVÉDERM™ Injectable Gel is available in three different concentrations, their use depending on the nature of the depression, needed to be corrected.
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Restylane®
Restylane® is a new form of injectable filler. It has many advantages over traditional options like collagen and fat injections such as durability. Restylane® is a transparent hyaluronic acid, biodegradable gel that is injected into facial tissue to smooth wrinkles and folds, especially around the nose and mouth. Hyaluronic acid is a protective, lubricating and binding gel substance that is produced naturally by body moisture. Also, Restylane® is non-animal based, which eliminates transmission of animal based diseases and pretesting to determine allergic reaction.
What is the treatment procedure?
Depending on each individuals needs and the amount of area the needs treatment, the procedure will generally last anywhere from a few minutes to half an hour. Using a thin gauge needle, small amounts of Restylane® is injected into areas of the facial tissue where moderate to severe facial wrinkles and folds occur. Restylane® enhances your appearance with a minimal amount of pain. To help minimize pain, patients can request a topical anesthetic and for lip sculpting, a local anesthesia will likely be used.
Choosing a qualified doctor or nurse practicioner trained in the use of Restylane® injection is important in achieving the best results
What are the results?
Restylane® temporarily shapes facial contours, smoothes wrinkles and sculpts lips, adding volume to facial tissue and restoring a smoother appearance to the face. The effects of Restylane® are practically instantaneous and last for about 6 months or sometimes longer. Restylane® will help smooth moderate to severe facial wrinkles and folds. In a clinical study, most patients needed one injection to achieve optimal wrinkle smoothing; about one-third of patients needed more than one injection to get a satisfactory result. Skin type, age, and daily activities can affect how long the results will last.
Wrinkles
Restylane® restores natural volume under the wrinkle, lifting the skin up to smooth out the surface of the face.
Facial Contours
Restylane® lifts up the skin from the cheeks and chin and corrects deep folds, allowing for a fuller shaped chin and a more shapely contour along the cheeks.
Lips Augmentation
Restylane® is injected into the inside of the upper and/or lower lip and also along the lip line to add more volume and an overall more youthful look.
*Two treatments a year are allowed and follow up treatments that are administered before the effects of the latter disappear will help the results to last. If further treatments are not scheduled, the pre-treatment facial state will gradually reappear.
What are the side effects?
Any side effects that may occur generally only last for one or two days, then dissipate. These effects may or may not include:
bruising
redness
swelling
pain
tenderness
itching
Who can provide the best results?
Choosing a qualified doctor or nurse practicioner trained in the use of Restylane® injection is important in achieving the best results
Important Information
Though no pre-testing is needed, aspirin, Vitamin E supplements and other medications should be avoided before treatment because they can increase bruising or bleeding.
Restylane® should not be used in patients who have:
severe allergies marked by a history of anaphylaxis ( hypersensitivity to the ingestion or injection of a drug or protein) ,
multiple severe allergies,
severe allergies to gram-positive bacterial proteins,
Restylane® should not be used for:
breast augmentation,
implantation into bone, tendon, ligament, or muscle, or
implantation into blood vessels, because it may obstruct blood flow.
For additional information:
http://www.fda.gov/OHRMS/DOCKETS/AC/03/briefing/4004b1_04_Lead%20Summary%20Memo.htm
SUMMARY LEAD REVIEW MEMO
Product Description:
Restylane® consists of non-animal, stabilized, hyaluronic acid (NASHA) at a concentration of 20 mg/ml, suspended in a physiological buffer pH 7. It is a clear, transparent, viscous and sterile gel, supplied in a disposable glass syringe. Each syringe contains 0.4 or 0.7 ml gel. The contents of the syringe are sterile. The syringe consists of a plunger stopper, finger grip and plunger rod. The syringe is packed in a blister together with a sterile 30 G needle.
Restylane® acts by adding volume to the tissue, thereby restoring the skin contours to the desired level of correction.
Indication for Use:
Restylane® is intended for temporary correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Marketing History
Restylane® was first approved for marketing and sale in September 1996 in the European Union including EES. Registration was obtained in Canada, Brazil, Hungary and Russia in 1998. In 1999 the product was registered in Australia, Argentina, Peru, Poland and Korea. In 2000 Ecuador, Mexico, Uruguay, Turkey and Singapore were added to the list of countries in which Restylane® is approved. Approval was obtained in Bulgaria, Columbia. Czech Republic, and Jordon in 2001.
Sales for 1997 amounted to 67,050 syringes and 457,385 syringes sold worldwide in 2001.
Restylane® has not been marketed in the United States was the subject of a clinical trial in the U.S.
Clinical Studies:
Two clinical studies have been performed in order to evaluate the safety and efficacy of Restylane® for the treatment of facial wrinkles and folds. The pivotal study is the primary evaluation of safety and effectiveness. The open-label extension is considered only for additional safety data. Only a very brief summary of the clinical studies is provided here. Please see the FDA clinical summary memo for complete summary information on the clinical study.
1. Pivotal Study: A Randomized, Evaluator-Blind, Multi-Center U.S. Study Comparing the Safety and Efficacy of Restylane® and Zyplast® for the Correction of Nasolabial Folds
Study Design: Randomized, double-blind, multi-center clinical study on Restylane® vs. Zyplast®. A total of 138 patients at 6 centers were randomized to obtain the optimal cosmetic result. The response of the initial treatment was evaluated after 2 weeks and in case of non-optimal cosmetic results a touch-up treatment could be performed. This procedure was repeated every two weeks until optimal response was achieved.
2. An open tolerance and efficacy study- A Non-Randomized Open Study of 112 Patients Receiving Restylane® for the Treatment of Depressed Cutaneous Scars, Wrinkles and Folds
This study was done at four clinics with 112 patients treated and followed for four months. The naso-labial folds were the most commonly treated site but the study also included treatment of facial wrinkles, scars and lips.
The original submission contained the results of the pivotal clinical study out to 6 months and an open-label extension to the study. The pivotal study is considered by FDA to be the primary study of safety and effectiveness. The open-label extension is considered only for additional safety data. For ease of review, it is helpful to understand the chronology of the submission. FDA determined that the 6-month follow-up data were inadequate to make a judgment on the safety of the product and requested that the sponsor provide 12 month data that were being collected. Additionally, we requested that the sponsor provide all safety data from all sources, including those from Europe and patient diaries. Based on the data in the original submission, FDA sent the sponsor a major deficiency letter on November 18, 2002 requesting information addressing overall safety data and data regarding hypersensitivity. The sponsor submitted an amendment (i.e., Amendment 3) in response to the major deficiency letter of November 18, 2002. The sponsor was sent another major deficiency letter on May 5, 2003, to address the issues of biocompatibility/toxicology of the cross-linker component, hypersensitivity, and lack of minority representation in the study. In response to that letter, the sponsor submitted another amendment (i.e., Amendment 5). These letters and the sponsor’s responses to the deficiencies are included on the CD ROM in the panel pack.
FDA ISSUES/CONCERNS
Restylane® contains small amounts of BDDE (1,4 butanediol diglycidulether), a potential sensitizer. Hypersensitivity was therefore a concern. The IDE protocol had specified that patients developing sensitivity reactions were to be skin tested. The sponsor pointed out that none of the investigators noted sensitivity reactions and therefore none of the patients were skin tested. FDA is concerned that some of the reactions noted during the study could be hypersensitivity reactions. The panel will be asked to comment on this issue.
In addition to questions about the overall effectiveness of Restylane®, FDA questions whether or not the data show Restylane® as superior to the control (Zyplast™). The sponsor bases their superiority claim on the majority of individual patient successes achieving a one-point improvement over the control in the Wrinkle Severity Rating Scale (SRS) from baseline at 6 months. The alternative approach is to look at the entire cohort of Restylane® versus Control and note that a full one-point improvement could not be achieved in the aggregate case (D = 0.58). The panel will be asked to discuss if Restylane® is superior to the Control.
In addition to questions about the overall safety of Restylane®, FDA has concerns about the lack of minority representation in the study. Minorities, particularly those with darker skin, may have more severe reactions to injections than populations with lighter skin. Noting that the study only included two African-Americans and ten patients listed as “other”, dark skin populations may have an increased risk of adverse reactions or poor cosmetic outcome. The panel will be asked to discuss if the sponsor should be required to conduct further studies on the issue and if Restylane® should include language in the labeling to address the lack of minorities in the study.
FDA also questioned whether the data in the PMA supported the proposed indications. The sponsor had only injected nasolabial folds bilaterally (i.e., control and treatment sides) yet the proposed indications include “…correction of moderate to severe facial wrinkles and folds...” FDA will also ask the panel to comment on the adequacy of the data for these proposed indications.
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Rosacea
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LASER HAIR REDUCTION
To schedule your appointment please call one of the convenient locations below:
Galleria/ River Oaks
4400 Post Oak Parkway
Suite2260
Houston, TX 77027
1-877-707-2277
713-799-9999
view map
Town & Country
12727 Kimberley
Suite 300
Houston, TX 77024
1-877-707-2277
713-799-9999
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Memorial Wellness Center
7731 Southwest Freeway
Suite 300
Houston, TX 77074
1-877-707-2277
713-799-9999
View Map
Directions & Parking | Visitor Information
FDA (Food and Drug Administration) approved, laser hair reduction has been proven a safe, effective way to rid various areas of the body of unwanted hair. The laser can be used on delicate facial skin, sensitive bikini areas, and legs of women as well as the more rough skin areas of a man like the back and under arms.
What areas can be treated?
Almost any area on the body can be treated. Any area adjacent to eye is the only area that can’t receive treatment. The most popular areas to be treated are the abdomen, back, bikini line, chest, face, legs, periareolar, and underarms.
How does the procedure work?
A laser beam is directed at the hair follicles of the area to be treated. The darker pigments in the hair follicle absorbs the laser light energy from the laser beam until the follicle dies and can no longer grow hair. The more treatments the patient receives, the more permanent the hair reduction becomes.
What are the results?
It is impossible to guarantee an exact result from the laser hair reduction treatment. Since there is no guaranteed outcome, how many treatments that will be needed overall can not be predicted and is completely dependant upon how well the laser treatment responds to each patient.
Skin and hair pigment does highly influence the outcome of laser hair reduction. Light skin, dark haired patients generally have the best outcomes. They need fewer treatments and the results are the most optimal and less time consuming. This does not mean that patients with darker skin pigment cannot be treated, though results are slower, more sessions are required, and greater expertise is needed on the doctor’s part for the best outcome. Darker hair responds best to laser treatment and coarse dark hair absorbs more laser energy. Those with blonde and red hair have a slower response to treatment because their hair usually contains pheomelanin, which doesn’t absorb laser energy as well as eumelanin that is present in black and darker shaded hair.
What are the side effects?
Occasionally, pigmentary change of the skin can occur. Pigmentary changes are typically temporary and begin to improve immediately and will last no longer than a few months. Blisters and burns rarely occur, but are possible. Patients with darker skin have a higher probability of burning because darker skin absorbs the laser energy more than lighter skin.
Who should not receive treatment?
Laser reduction is effective for most patients when properly performed, though there are certain circumstances that should be noted. Patients with darkly tanned skin and lighter pigmented hair may not find laser hair reduction very beneficial. Patients with blonde hair and red hair with a dark tan should especially be precautious of treatment. Also, those that cannot afford multiple treatments are not good candidates because one treatment is rarely enough.
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Psoriasis
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Eczema
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Skin-Exposure.html
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skin cancer colorado springs
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skin
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Facelift Video
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Liposuction Video
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Breast Augmentation Video
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