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CompletedNCT01012388Updated Apr 26, 2013Results posted

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

A Phase 4 interventional study of Radiesse® Injectable Dermal Filler in Nasolabial Folds, sponsored by Merz North America, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-26.

Sponsored by Merz North America, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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

02

Conditions studied

  • Nasolabial Folds

Keywords

  • Moderate to severe wrinkles and folds such as nasolabial folds
03

In context

Lead sponsor

Merz North America, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Is at least 18 years of age.
  • Has Fitzpatrick Skin Type IV, V, or VI.
  • Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months.

Exclusion criteria

Exclusion Criteria:

  • Has history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
  • Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
  • Has nasolabial folds that are too severe to be corrected in one treatment session.
  • Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold.
  • Is pregnant, lactating, or not using acceptable contraception.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Radiesse

    Device: Radiesse® Injectable Dermal Filler

Interventions

  • DeviceRadiesse® Injectable Dermal Filler

    Calcium hydroxylapatite particles suspected in an aqueous based gel carrier

06

What researchers measure

Primary outcomes

  1. Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment

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

    Time frame: 3 months

  2. Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment

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

    Time frame: 6 months

07

Results

Posted Dec 23, 2009

Participant flow

Participant flow — Overall Study
MilestoneRadiesse Injectable Dermal Filler
Started100
Completed100
Not completed0

Outcome measures

PrimaryNumber Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment

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

Time frame:
3 months
Reported as:
Number · Participants
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment
ParticipantsRadiesse Injectable Dermal Filler
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment0
PrimaryNumber Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment

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

Time frame:
6 months
Reported as:
Number · participants
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment
participantsRadiesse Injectable Dermal Filler
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment0

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Radiesse Injectable Dermal Filler—0/100 (0%)27/100 (27%)
Most frequent other events
Most frequent other events
EventRadiesse Injectable Dermal Filler
RednessSkin and subcutaneous tissue disorders16/100
SwellingSkin and subcutaneous tissue disorders12/100
BruisingSkin and subcutaneous tissue disorders7/100

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Radiesse Injectable Dermal Filler
<=18 years0
Between 18 and 65 years88
>=65 years12
Age Continuous
Age Continuous(years)Radiesse Injectable Dermal Filler
Mean52 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)Radiesse Injectable Dermal Filler
Female94
Male6
Region of Enrollment
Region of Enrollment(participants)Radiesse Injectable Dermal Filler
United States100
08

Study locations

5 sites
  • Los Angeles, California, United States
  • Chevy Chase, Maryland, United States
  • Ypsilanti, Michigan, United States
  • New York, New York, United States
  • Philadelphia, Pennsylvania, United States
09

References and documents

Publications

  • Marmur ES, Taylor SC, Grimes PE, Boyd CM, Porter JP, Yoo JY. Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI. Dermatol Surg. 2009 Oct;35 Suppl 2:1641-5. doi: 10.1111/j.1524-4725.2009.01311.x. Epub 2009 Aug 25. PubMed 19708876 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01012388
Lead sponsor
Merz North America, Inc.
Responsible party
Sponsor
First posted
Nov 13, 2009
Start date
Mar 2007
Primary completion
Dec 2007
Completion
Feb 2008
Results posted
Dec 23, 2009
Last update
Apr 26, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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