Medication Guide App

Perlane

Generic Name: non-animal stabilized hyaluronic acid (NASHA) injectable gel
Company: Medicis Aesthetics Inc.
Treatment for: Correction of Facial Wrinkles/Folds

What is Perlane?

Perlane is an FDA-approved dermal filler for implantation into the skin for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds. Perlane is generated by a Streptococcus species of bacteria.

Perlane differs from Restylane primarily in the size of the particles and the depth of the required injection. Perlane, used for deeper wrinkles, has larger particles that are injected deeper into the skin than Restylane. Perlane is not approved for use in lip enhancement, but Restylane can be used for this purpose in patients 21 years of age and older. Clinical studies showed no significant differences in the safety of Restylane and Perlane.

Perlane is comprised of biotechnologically engineered, non-immunogenic, stabilized hyaluronic acid gel particles. Hyaluronic acid is a natural substance found in all living organisms and provides volume and fullness to the skin. The three-dimensional gel particles in Perlane are hydrophilic molecules, attracting and binding to water molecules as they degrade, helping to maintain volume augmentation for about six months.

Perlane should only be administered under the supervision of a licensed practitioner.

Perlane Clinical Trials

Four U.S. clinical trials in over 500 patients were completed in support of the approved uses for Perlane. These trials evaluated the safety and effectiveness in mid-to-deep skin injection for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

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Perlane was shown to be effective when compared to other dermal fillers with respect to the correction of moderate to severe facial folds and wrinkles. Studies showed that at three months roughly 87 to 92 percent of patients reported an improvement in wrinkles, and at six months 63 to 71 percent of patients were still reporting improvements.

Perlane Side Effects

Four U.S. studies reported side effects with Perlane. Rates of side effects with Perlane were primarily compared with rates of side effects from Restylane, a similar hyaluronic acid dermal filler. In two studies (n=433), side effects were collected via patient diaries for 14 days after injection. Side effects from studies conducted in moderate to severe facial wrinkles and folds, such as nasolabial folds (n=505 subjects) were as follows:

  • Bruising
  • Redness
  • Swelling
  • Pain/Soreness
  • Tenderness
  • Itching

Most side effects occurred in 70 to 90 percent of patients, except for itching, which occurred in roughly 30 percent of patients. The type of side effects reported with Perlane were similar to Restylane. Greater than 95 percent of patients were no longer reporting side effects two weeks after treatment. Side effects were rated as none or tolerable in most patients when they were questioned about the intensity of symptoms.

Physician and investigator-reported side effects were identified at 72 hours and 14 days after injection, and were similar to those reported by patients. Other investigator-identified side effects that occurred in less than 2 percent of patients at 72-hours after Perlane injection included:

  • Hyperpigmentation
  • Papule
  • Herpes eruption and reactivation

Rare post-marketing serious adverse events

  • Immediate or delayed hypersensitivity reactions
  • Granuloma
  • Injection site reactions
  • Broken capillaries

Patient Information1

What is Perlane used for?

Perlane is used to smooth moderate to severe facial folds and wrinkles such as the lines from the nose to the corners of the mouth (nasolabial folds). Perlane generally lasts for about 6 months. It has been found to be a safe dermal filler that restores volume and fullness to the skin.

How does Perlane work?

Perlane is injected into the skin with an ultrafine needle. It plumps the skin to smooth away wrinkles and folds. Perlane attracts and binds water molecules to help maintain volume. Perlane is composed of hyaluronic acid. The hyaluronic acid in Perlane is a clear gel that is chemically cross-linked (the long chemical strands are tied together) to delay breakdown by skin enzymes. Perlane is non-animal-based and free from animal protein. This quality prevents disease transmission. Allergy pre-testing is not necessary.

How long does Perlane last?

Studies have shown that Perlane effects generally last about six months. Perlane is gradually broken down and eliminated by the body.

Who should not use Perlane (Contraindications)?

Perlane should not be used

  • by people with previous severe allergies (especially to gram positive bacteria)
  • severe allergies or anaphylaxis to drugs that have required in-hospital treatment
  • in people with bleeding disorders

Perlane should not be injected anywhere except the skin or just under the skin. Perlane must not be implanted into blood vessels. Localized superficial necrosis may occur after injection in or near dermal vessels.

What are the warnings or side effects to consider?

The use of Perlane at sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of Perlane in these instances could delay healing or make your skin problems worse.

You may experience skin discoloration (bruising), swelling, redness, tenderness, pain, itching, or small lumps in the area where you are injected. If any of these events occur, the majority usually last less than seven days. If any symptom lasts longer than two weeks, call the doctor who administered the Perlane injection.

Inflammatory papules (red or swollen small bumps) may rarely occur. You may need antibiotics to treat them.

What are some risks that may be experienced?

As with all procedures like this, the injection of Perlane carries a theoretical risk of infection and formation of scar tissue. The safety and effectiveness of Perlane have not been established in the treatment of lips, in nursing mothers, and in patients under 18 or over 65 years of age. Perlane use in nursing could harm you or the nursing child.

The use of Perlane in African-American patients can result in hyperpigmentation (darkening of skin color), which may take several weeks to correct.

If you have had herpes before, Perlane injection can cause the herpes to come back. The safety of Perlane used with other skin therapies such as laser, mechanical or chemical peeling, and hair removal has not been established. The use of Perlane in these skin therapies may not work or they may damage your skin.

You should avoid exposing the area treated with Perlane to excessive sun or UV lamps, and extreme heat and cold until any redness or swelling has disappeared.

What are the major side effects?

Rarely, the doctor may inadvertently inject the product into a blood vessel, which can cause injury to the blood supply and damage to the skin.

Rarely, a few people have developed infections of the gel that must be treated with antibiotics or other treatment. Infection of the gel may be hard to treat, but will always go away when the gel is absorbed.

What should patients do prior to treatment?

Perlane requires no pretesting, but you should take a few precautions before being treated. Avoid using St. Johns Wort, high doses of Vitamin E supplements, aspirin, and other non-steroidal anti-inflammatory medications, such as ibuprofen prior to treatment, because these may increase bruising or bleeding at the injection site. Also, if you have previously suffered from facial cold sores, discuss this with your physician. He or she may consider prescribing a medication to minimize recurrence.

Do the injections hurt?

Perlane is injected directly into the skin in tiny amounts by an ultrafine needle. To help maximize your comfort, you should discuss the use of numbing medicines with your doctor before treatment.

How much do Perlane treatments cost?

Perlane is a customized procedure based on your specific needs, so the cost will vary from patient to patient. In general, the cost of Perlane is comparable to the cost of similar dermal filler procedures. Please ask your doctor to give you an estimate of the cost.

What should I call my doctor about after the treatment?

Most side effects like bruising, swelling, pain, tenderness, redness, and itching will usually go away within one to two weeks. Call your doctor if you have persistent problems beyond 14 days.
Blisters or skin sores may signal that you are having a recurrent herpes infection that should be treated.

You can develop an infection that should be treated with antibiotics. If you experience redness, tenderness, and pain that does not go away you should call your doctor.

What is the dose of Perlane?

The amount used depends on your face and what you would like to have treated. The average patient who has all of the severe wrinkles around the mouth corrected will use less than half of a tablespoon. Based on U.S. clinical studies patients should be limited to 6 mL per patient per treatment. The safety of injecting greater amounts has not been established.

Post-Treatment Checklist

Please observe the following after treatment with Perlane:

  • Cold compresses (a cloth dipped in cold water, wrung out, and applied to the injected area) may be used immediately after treatment to reduce swelling.
  • Avoid touching the treated area within six hours following treatment so you do not accidentally injure your skin while the area is numb. After that, the area can be gently washed with soap and water.
  • Until there is no redness or swelling, avoid exposure of the treated area to intense heat (sun lamp or sun bathing).
  • If you have previously suffered from facial cold sores, there is a risk that the needle punctures could contribute to another occurrence. Speak to your physician about medications that may minimize a recurrence.
  • Avoid taking aspirin, non-steroidal anti-inflammatory medications, St. Johns Wort, and high doses of vitamin E supplements for one week after treatment. These agents may increase bruising and bleeding at the injection site.

For more information, please visit www.medicis.com.

References:

  1. Perlane. [package insert] Scottsdale, AZ. Medicis Aesthestics Inc. 2010 August.

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