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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merz Pharmaceuticals, LLC

ClinicalTrials.gov Identifier:

NCT01012388

First received: November 11, 2009

Last updated: April 19, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 11, 2009
Last Updated Date	April 19, 2013
Start Date ^ICMJE	March 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 3, 2010)	Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely
Original Primary Outcome Measures ^ICMJE (submitted: November 12, 2009)	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 by physical exam [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT01012388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
Official Title ^ICMJE	Post-Marketing Study of Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Nasolabial Folds
Intervention ^ICMJE	Device: Radiesse® Injectable Dermal Filler Calcium hydroxylapatite particles suspected in an aqueous based gel carrier
Study Arm (s)	Experimental: Radiesse Intervention: Device: Radiesse® Injectable Dermal Filler
Publications *	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. Epub 2009 Aug 25.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	February 2008
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01012388
Other Study ID Numbers ^ICMJE	P1206248
Has Data Monitoring Committee	No
Responsible Party	Merz Pharmaceuticals, LLC
Study Sponsor ^ICMJE	Merz Pharmaceuticals, LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merz Pharmaceuticals, LLC
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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