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NCT01147172 · ClinicalTrials.gov registry record · NA
Safety Study of Cosmetic Tissue Augmentation in People of Color
A NA study, sponsored by Anika Therapeutics.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01147172 is a NA study that has completed, run by Anika Therapeutics. The registered enrollment target is 100 participants.
The verdict
NCT01147172, a NA study, has completed, sponsored by Anika Therapeutics.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
Elevess is intended for all skin types. However, further study of all soft tissue fillers is needed in people of color because of the increasing use of cosmetic dermal filler products. This study is designed to evaluate the safety of an injectable hyaluronic acid based dermal filler Elevess (Anika Therapeutics, Inc., Bedford, MA). Safety will be evaluated by incidence and severity of keloid formation and pigmentation changes, and other potential adverse events in people with Fitzpatrick skin types IV, V and VI who have elected to undergo nasolabial fold (NLF) treatment with Elevess. 1\. Fitzpatrick Classification of Skin Type as: IV - Burns minimally, always tans well (moderate/light brown skin; Mediterranean, Asian, Hispanic. V - Rarely burns, tans profusely (dark brown/brown skin: Middle eastern, Latin, light skinned Black, Indian) VI - Never burns, (deeply pigmented dark brown to black skin;Black)
Interventions
- DEVICE Elevess
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01147172
The ClinicalTrials.gov registry entry for NCT01147172 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anika Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Elevess is the first listed.
NCT01147172 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01147172 about?
NCT01147172 is a clinical study titled "Safety Study of Cosmetic Tissue Augmentation in People of Color". Elevess is intended for all skin types. However, further study of all soft tissue fillers is needed in people of color because of the increasing use of cosmetic dermal filler products. This study is designed to evaluate the safety of an injectable hyaluronic acid based dermal filler Elevess (Anika ...
What is the current status of trial NCT01147172?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2009-03. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01147172?
The interventions under investigation include: Elevess (DEVICE).
Who is sponsoring clinical trial NCT01147172?
This trial is sponsored by Anika Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
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