Phase 4
Completed N=100
Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
Nasolabial Folds
Source: ClinicalTrials.gov NCT01012388 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcomePrimary: 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
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
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 |
— | — |
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.
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. Informational only — not medical advice.