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Clinical Studies

Study Design

A prospective, double blind, randomized, multi-center clinical study was conducted to evaluate the safety and effectiveness of Hylaform gel when used as a dermal filler in the nasolabial folds. Patients were randomized between Hylaform gel and a commercially available control material, Zyplast implant (derived from bovine collagen) and were injected with enough material to achieve desired correction of each nasolabial fold. (Patients enrolled into the study underwent double bovine collagen skin testing.) At 2 weeks touch-up treatment with additional material was allowed, only if patients showed less than a 1-point improvement on the 6-point grading scale (see DESCRIPTION below).

The primary efficacy endpoint for the study was the ability to correct nasolabial folds at 12 weeks in comparison to the control material. Correction of nasolabial folds was determined by an independent panel of blinded dermatologists through photographic assessment. Photographs of nasolabial folds were taken prior to treatment and at 3 days, 2, 4, 8, and 12 weeks following treatment. A 6-point grading scale was used to rank wrinkle severity for each photograph in a random, blinded fashion. Additional analyses included the investigator's visual assessment of each patient's nasolabial folds using the 6-point grading scale, and a qualitative assessment of the level of correction by the investigator and by the patient.

Table 2 : Demographics and Pretreatment Characteristics of Total Patient Population, N=261 [Number (% of Patients]

Gender   Tobacco use  
  Male 16 (6.1)   Non-smoking 216(82.7)
  Female 245 (93.9)   Smokers 45 (17.2)
Ethnicity Sun Exposure (mean) 1.6 hrs/day
  Caucasian 208 (79.7)  
  African American 5(1.9) Patients With Prior Dermal Treatments 157 (60.1)
  Asian 9 (3.4)    
  Hispanic 34(13.0)    
  Other 5(1.9)    

Treatment Material Delivered

The mean total volume injected per nasolabial fold was 0.8 mL for patients in the treatment group (Hylaform gel) and 1.1 mL for patients in the control group (Zyplast implant). The mean volume injected was the same for left and right nasolabial folds and was approximately equivalent to the total volume supplied in one syringe of Hylaform gel (0.75 mL) and of Zyplast implant (1.0 mL) for the clinical study.

Twenty-two (16.5%) of 133 Hylaform patients and 9 (7.1%) of the 128 Zyplast patients required a touch-up treatment. The mean volume injected for touch-up per nasolabial fold was 0.3 mL for Hylaform patients and 0.5 mL for Zyplast patients.

Hylaform Gel Efficacy

Hylaform gel was found to be equivalent to the control materia! (Zyplast implant) in the correction of nasolabial folds after 12 weeks using the independent review of photographs.

Mean Score Based on 6-Point Grading Scale

  Blinded Photographic Assessment
Pretreatment 12 Weeks after Treatment
Hylaform 2.2 2.3
Zyplast 2.3 2.2
Grading scale: 0=No wrinkles, 1=Just perceptible wrinkle, 2=Shallow wrinkles, 3=Moderately deep wrinkle, 4=Deep wrinkle, well-defined edges, 5=Very deep wrinkle, redundant fold

Peak treatment effect with one injection of Hylaform gel was observed during the first 2 weeks after treatment. Photographic assessment showed that, on average, patients had returned to baseline in both groups at 12 weeks. However, the secondary endpoints of investigator's visual assessment and a qualitative assessment of correction by the investigator and by the masked patient during the controlled clinical study support the effectiveness of Hylaform and Zyplast at 12 weeks.

Mean Score Based on 6-Point Grading Scale

  Investigator Live Assessment
Pretreatment 12 weeks after treatment
Hylaform 3.5 2.4
Zyplast 3.5 2.3
Grading scale: 0=No wrinkles, 1 =Just perceptible wrinkle, 2=Shallow wrinkles, 3-Moderately deep wrinkle, 4=Deep wrinkle, well-defined edges, 5=Very deep wrinkle, redundant fold

Based on investigator live assessment, 15% of Hylaform patients and 10% of Zyplast patients returned to pretreatment levels at 12 weeks.

Last reviewed on RxList: 7/11/2013
This monograph has been modified to include the generic and brand name in many instances.

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