HArmonyCa Split-face Pilot Study - Luminera

HArmonyCa Split-face Pilot Study

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A Prospective, Randomized, Double Blinded, Controlled, Non-inferiority, Split Face Study Comparing HArmonyCa Lidocaine with Radiesse (+) for the Correction of Nasolabial Folds

Study

Main Goal

Compare the effectiveness and safety of HArmonyCa Lidocaine to Radiesse (+) for the correction of Nasolabial folds (NLFs). 

Study

Main Goal

Compare the effectiveness and safety of HArmonyCa Lidocaine to Radiesse (+) for the correction of Nasolabial folds (NLFs). 

Study Design

Visits​

Endpoints​

HArmonyCa in one side and Radiesse in the other side
6 subjects (blinded to product side)
Study center: Assaf Harofeh Medical Center
Principal Investigator Proffesor L. Heller

1

2

3

4

Treatment

Touch up (optional)

1 month follow up

3 months follow up

AEs comparison
Assessment of before and after photographs
Pain perception assessment
Satisfaction questionnaires

Patient Data​

Patient #

AGE

SEX

Fitzpatrick skin type

P01

0

F

3

P02

0

F

3

P03

0

F

3

P04

0

F

3

P05

0

F

3

P06

0

F

3

Injected Volumes

RIGHT SIDE

LEFT SIDE

Patient #

Region of Injection​

1st Side Injected​

Product​

Amount Injected (ml)​

Product​

Amount Injected (ml)​

P01

Cheek

Radiesse

HArmonyCa

1.05

Radiesse

1.25

P02

Cheek

Radiesse

HArmonyCa

1.25

Radiesse

1.10

P03

NLFs

Radiesse

Radiesse

0.50

HArmonyCa

0.65

P04

NLFs

HArmonyCa

Radiesse

1.00

HArmonyCa

0.85

P05

NLFs

Radiesse

HArmonyCa

0.55

Radiesse

0.50

P04

NLFs

HArmonyCa

Radiesse

0.65

HArmonyCa

0.70

STUDY RESULTS
Patient’s Pain Perception
Patient's pain rating scores for each product
immediately after treatment
GAIS - Global Aesthetic Improvement Scale
Efficiency Results
Performance as per GAIS Scores​

HArmonyCa side

Radiesse side

P01

2

3

P02

3

5

P03

2

3

P04

3

4

P05

4

4

P06

3

3

Mean

2.83

3.66

Performence Using GAIS​

1

Very much improved in this patient

2

Much Improved

3

Improved

4

No Change

5

Worse
Study Results
Summary​

HArmonyCa lidocaine injection was less painful than Radiesse (+) .
HArmonyCa lidocaine treatment had less side effects than Radiesse (+) .
Higher performance results for HArmonyCa according to GAIS.

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