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

NCT01012388 | Completed Phase 4 Results

• 1 other identifier: P1206248
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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

Conditions

Nasolabial Folds

Keywords

Moderate to severe wrinkles and folds such as nasolabial folds

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely

  6 months

Study Arms (1)

Radiesse

EXPERIMENTAL

Device: Radiesse® Injectable Dermal Filler

Interventions

Radiesse® Injectable Dermal Filler DEVICE

Calcium hydroxylapatite particles suspected in an aqueous based gel carrier

Radiesse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (5)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Chevy Chase, Maryland, United States

Location

Unknown Facility

Ypsilanti, Michigan, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Related Publications (1)

• Marmur ES, Taylor SC, Grimes PE, Boyd CM, Porter JP, Yoo JY. Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI. Dermatol Surg. 2009 Oct;35 Suppl 2:1641-5. doi: 10.1111/j.1524-4725.2009.01311.x. Epub 2009 Aug 25.

  PMID: 19708876 RESULT

Results Point of Contact

• Title: Merz Aesthetics, Inc.
• Organization: Merz Aesthetics, Inc.

clinicaltrials@merzaesthetics.com

650-286-4041

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: March 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: February 1, 2008
• Last Updated: April 26, 2013
• Results First Posted: December 23, 2009

Record last verified: 2013-04

Locations

US (5)