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

Merz Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Nasolabial Folds

Treatments: Device: Radiesse® Injectable Dermal Filler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012388

P1206248

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Radiesse

Experimental group

Treatment:

Device: Radiesse® Injectable Dermal Filler