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Sponsors and Collaborators: |
Genzyme Inamed Aesthetics |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00293163 |
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.
Condition | Intervention | Phase |
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Facial Wrinkles |
Device: Hylaform, Hylaform Plus (hylan B gel) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
Estimated Enrollment: | 120 |
Study Start Date: | February 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Vitiligo & Pigmentation Institute of Southern California | |
Los Angeles, California, United States, 90036 | |
United States, Michigan | |
Grekin Skin Institute | |
Warren, Michigan, United States, 48088 | |
United States, Pennsylvania | |
Society Hill Dermatology | |
Philadelphia, Pennsylvania, United States, 19107 |
Study Director: | Patricia Walker, M.D. | Inamed Aesthetics |
Study ID Numbers: | HYLA00204 |
Study First Received: | February 16, 2006 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00293163 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Facies |