Nasolabial Folds
Conditions
Keywords
Moderate to severe wrinkles and folds such as nasolabial folds
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
Interventions
Calcium hydroxylapatite particles suspected in an aqueous based gel carrier
Sponsors
Merz North America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment | 3 months | Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiesse Injectable Dermal Filler Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Radiesse Injectable Dermal Filler |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants |
| Age Continuous | 52 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 94 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
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
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiesse 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 Treatment | 0 Participants |
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
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiesse 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 Treatment | 0 participants |