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.
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
