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NCT01012388 · ClinicalTrials.gov registry record · Phase 4

Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color

A Phase 4 study, sponsored by Merz North America.

Completed
Registry status
Phase 4
Development phase
100
Enrollment target

NCT01012388: Completed Phase 4 study, sponsored by Merz North America.

NCT01012388 is a Phase 4 study that has completed, run by Merz North America. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01012388, a Phase 4 study, has completed, sponsored by Merz North America.

COMPLETED
Registry status
Phase 4
Development phase
100 participants
Enrollment target

Study Summary

Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler

Primary Outcome

Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely

Interventions

  • DEVICE Radiesse® Injectable Dermal Filler

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2007-03
Est. Completion 2008-02
Phase Phase 4
Merz North America

35 total trials

What the finished NCT01012388 record still lists

NCT01012388 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 1 intervention - of which Radiesse® Injectable Dermal Filler is the first listed.

NCT01012388 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01012388 about?

NCT01012388 is a clinical study titled "Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color". Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler

What is the current status of trial NCT01012388?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2007-03. Estimated completion is 2008-02.

What interventions are being tested in trial NCT01012388?

The interventions under investigation include: Radiesse® Injectable Dermal Filler (DEVICE).

Who is sponsoring clinical trial NCT01012388?

This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01012388's enrollment target sits among peer trials

100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT01012388, the US trial registry maintained by the National Library of Medicine. NCT01012388 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.