Phase 4 N=100 Treatment

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

Nasolabial Folds

Bottom Line

View on ClinicalTrials.gov: NCT01012388 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Dec 2009

Primary outcome: Primary: Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Radiesse® Injectable Dermal Filler (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merz North America, Inc.
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment	—	—
PRIMARY Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment	—	—

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

Eligibility Criteria

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01012388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.