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NCT00293163 Clinical Trial

A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique.

Facial Wrinkles Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00293163
Other study ID # HYLA00204
Secondary ID
Status Completed
Phase Phase 4
First received February 16, 2006
Last updated March 4, 2015
Start date February 2006
Est. completion date October 2006

Study information
Verified date March 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To assess the likelihood of keloid and scar formation, pigmentation disorders and hypersensitivity reactions in patients with skin of color undergoing correction of facial soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale

Exclusion Criteria:

- pregnant/lactating women

- patients who previously received permanent facial implants or using over-the-counter products

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Hylaform, Hylaform Plus (hylan B gel)

Locations
Country Name City State
United States Vitiligo & Pigmentation Institute of Southern California Los Angeles California
United States Society Hill Dermatology Philadelphia Pennsylvania
United States Grekin Skin Institute Warren Michigan

Sponsors (2)
Lead Sponsor Collaborator
Genzyme, a Sanofi Company Inamed Aesthetics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary no difference in keloid and scar formation
Primary pigmentation disorders
Primary hypersensitivity reactions in patients with skin color compared to other patients when treated for wrinkle correction with Hylaform, Hylaform Plus or Captique
See also
  Status Clinical Trial Phase
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Completed NCT00978887 - Retorna Facial Cream in the Treatment of Facial Wrinkles Phase 3
Completed NCT00414544 - Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds Phase 2
Completed NCT00888914 - Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines Phase 2
Completed NCT00877279 - Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft Phase 3
Completed NCT01124565 - Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults Phase 2
Completed NCT00922623 - Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI N/A
Not yet recruiting NCT03836638 - The Impact of Age on Botulinum Toxin Potency in Facial Rhytides Treatment N/A
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Completed NCT01566396 - Evaluation of Safety and Efficacy of the 3F Applicator (A3F) for Treatment of Facial Wrinkles N/A
Completed NCT01151436 - Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers N/A
Completed NCT06321770 - Oral Supplementation With Active Collagen Peptides and Skin Health Improvement N/A
Completed NCT01379365 - Cryo-Touch III Refinement Study Investigational Plan Phase 2/Phase 3
Completed NCT00288470 - A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast. N/A
Completed NCT02122536 - Split-Face Prospective Study Comparing Botox to Xeomin for the Treatment of Facial Wrinkles N/A
Completed NCT01167140 - Cryo-Touch II for the Treatment of Wrinkles Phase 2/Phase 3
Completed NCT00968825 - Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines Phase 2
Completed NCT03286283 - The Use of J-Plasma® for Dermal Resurfacing N/A
Completed NCT01064518 - Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults Phase 2
Completed NCT00417469 - A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs) Phase 3