Trial Outcomes & Findings for Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color (NCT NCT01012388)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

3 months

Results posted on

2013-04-26

Participant milestones
Measure	Radiesse Injectable Dermal Filler Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Radiesse Injectable Dermal Filler n=100 Participants Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	88 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age Continuous	52 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants

Timeframe: 3 months

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

Outcome measures
Measure	Radiesse Injectable Dermal Filler n=100 Participants Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment	0 Participants

Timeframe: 6 months

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

Outcome measures
Measure	Radiesse Injectable Dermal Filler n=100 Participants Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment	0 participants

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Radiesse Injectable Dermal Filler n=100 participants at risk Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
Skin and subcutaneous tissue disorders Redness	16.0% 16/100
Skin and subcutaneous tissue disorders Bruising	7.0% 7/100
Skin and subcutaneous tissue disorders Swelling	12.0% 12/100

Phone: 650-286-4041

Principal investigator is a sponsor employee Sponsor reserves right to review/comment on manuscript intended for publication/presentation which presents trial data. No manuscripts may be submitted for publication without prior review/comment by Sponsor. Title, right to determine disposition of any copyrights, or copyrightable material, first produced/composed in the performance of this research shall remain with PI, provided that PI grants Sponsor irrevocable right to reproduce/translate/use all such copyrighted material for own purposes.
Publication restrictions are in place

Restriction type: OTHER