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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030032 / PAS001 |
| Date Original Protocol Accepted |
04/22/2004
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| Date Current Protocol Accepted |
04/22/2004
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| Study Name |
Fitzpatrick skin types
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| Device Name |
HYLAFORM (HYLAN B GEL)
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a 24- week, open-labeled, randomized, multi-center study to evaluate the safety of the Hylaform family dermal fillers in the augmentation of dermal tissue to temporarily correct the wrinkle and nasolabial folds in patients of Fitzpatrick Skin Types IV, V and VI. Eligible patients will be randomized (1:1:1 ratio) to receive a single treatment of one of the three dermal fillers (Hylaform, Hylaform Plus, and Captique Injectable Gel), which will be injected intradermally to both nasolabial folds.
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| Study Population |
Study population: Patients with Fitzpatrick Skin Phototypes IV, V, or VI. Indication: Correction of the nasolabial folds with Hylaform, Hylaform Plus, or Captique.
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| Sample Size |
100 patients, 3 sites
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| Key Study Endpoints |
Safety endpoints include keloid formation, hypertrophic scarring, hypopigmentation, hyperpigmentation, and symptoms of potential hypersensitivity. In addition, serum IgG antibody titers will be assessed at each visit. Effectiveness will not be evaluated in this study.
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| Follow-up Visits and Length of Follow-up |
The patients will return for safety assessments at weeks 2, 4, 12, and 24 months. Baseline and follow-up blood samples (at weeks 4 and 12) will be collected to measure the serum IgG antibody to determine immunological response to the devices. The length of follow-up is 24 weeks (up to additional 24 weeks if needed).
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| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
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| Actual Number of Patients Enrolled |
119 subjects were randomized and treated (39 Hylaform, 41 Hylaform Plus, and 39 Captique)
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| Actual Number of Sites Enrolled |
3 sites
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| Patient Follow-up Rate |
98%
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| Final Safety Findings |
There were no reports of keloid formation, hypertrophic scarring, hypopigmentation, or symptoms of potential hypersensitivity. Three patients experienced mild, device-related hyperpigmentation [two (4.9%) in the Hylaform Plus group and one (2.6%) in the Captique group) > The hyperpigmentation resolved within 3 months using a mild bleaching agent]. Approximately 28.6% (34/119) of the subjects in the treatment group experienced a total of 78 Treatment Emergent Adverse Events, most of which had short duration (7 days or less), and mild severity. The most common Treatment Emergent Adverse Events was injection site bruising (13.4%), followed by injection site nodule (5.0%), pain (4.2%), and swelling (3.4%). The duration of the most common TEAEs that lasted longer than 7 days (injection site nodules) ranged from 70 to 85 days. There were no deaths or no immunological positive responses. One angioedema occurred in the Captique group and the patient recovered the same day without intervention.The results from this study with persons with skin color are similar to that observed in the Hylaform/Hylaform Plus pivotal studies with mostly Caucasians.
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| Study Strengths & Weaknesses |
The strength was that is was a randomized study with concurrent controls to evaluate device safety. The weakness of the study was that patients received only one single treatment of one of the three dermal fillers and that no additional touch-up was allowed. It is not clear if the results can be extrapolated to postmarket when under the general conditions of use where the repeated treatments are likely.
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| Recommendations for Labeling Changes |
Based on the results of the post-approval study, the sponsor changed the label of Captique to include an update of the precaution section and an addition of the PAS study data. The sponsor updated only the Captique labeling as Hylaform and Hylaform Plus are no longer manufactured
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