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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: Completed NA study, sponsored by Anika Therapeutics.
NCT01147172 is a NA study that has completed, run by Anika Therapeutics. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
Percentage of Subjects with keloid formation at the site of injection
Interventions
- DEVICE Elevess
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-08 |
| Phase | NA |
What the finished NCT01147172 record still lists
NCT01147172 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Elevess is the first listed.
NCT01147172 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01147172's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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