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

Nasolabial Folds Clinical Trial

Official title:

Post-Marketing Study of Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012388
• Other study ID #: P1206248
• Status: Completed
• Phase: Phase 4
• First received: November 11, 2009
• Last updated: April 19, 2013
• Start date: March 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• Radiesse® Injectable Dermal Filler
Calcium hydroxylapatite particles suspected in an aqueous based gel carrier

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	3 months	Yes
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	6 months	Yes