Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
Phase 4
Completed
- Conditions
- Nasolabial Folds
- Interventions
- Device: Radiesse® Injectable Dermal Filler
- Registration Number
- NCT01012388
- Lead Sponsor
- Merz North America, Inc.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiesse Radiesse® Injectable Dermal Filler -
- Primary Outcome Measures
Name Time Method Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment 6 months Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely
- Secondary Outcome Measures
Name Time Method