CompletedPhase 4

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

United States100 participantsStarted 2007-03

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 3 months

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

Timeframe: 6 months

Trial details

NCT IDNCT01012388

SponsorMerz North America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-12

Results submitted2009-11-19

View on ClinicalTrials.gov More Nasolabial Folds trials