Trial Outcomes & Findings for Injectable Filler for Cheek Flattening (NCT NCT01225354)

Results Overview

Upon completion of the study, 300 blinded evaluators will evaluate one of three binders comprised of a random visit photographs from baseline, optimal cosmetic result, and 1 month post optimal cosmetic result of 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria. A score of 10 means favorable results and a score of 1 means unfavorable results.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

After the 1-month post optimal correction visit for 20 subjects (averaged)

Results posted on

2020-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Calcium Hydroxylapatite Subject will be treated at baseline and, if needed, at 2 weeks.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Injectable Filler for Cheek Flattening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calcium Hydroxylapatite n=20 Participants Subject will be treated at baseline and, if needed, at 2 weeks.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	48.2 years STANDARD_DEVIATION 9.71 • n=93 Participants
Sex: Female, Male Female	20 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants

PRIMARY outcome

Timeframe: After the 1-month post optimal correction visit for 20 subjects (averaged)

Upon completion of the study, 300 blinded evaluators will evaluate one of three binders comprised of a random visit photographs from baseline, optimal cosmetic result, and 1 month post optimal cosmetic result of 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria. A score of 10 means favorable results and a score of 1 means unfavorable results.

Outcome measures

Outcome measures
Measure	Calcium Hydroxylapatite n=19 Participants Subject will be treated at baseline and, if needed, at 2 weeks. Calcium hydroxylapatite: Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
Blinded Evaluations of First Impression	7.35 score on a scale Interval 6.15 to 8.5

PRIMARY outcome

Timeframe: 1 month

Population: All subjects completing indicated visit

Self-esteem change will be determined by patient self-evaluation using the Heatherton \& Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. A 20-item scale that measures a participant's self-esteem at a given point in time. The 20 items are subdivided into 3 components of self-esteem: (1) performance self-esteem, social self-esteem, and appearance self-esteem. All items are answered using a 5-point scale (1= not at all, 2= a little bit, 3= somewhat, 4= very much, 5= extremely). Scores range from 20-100. Scores closer to 100 indicate a more favorable outcome.

Outcome measures

Outcome measures
Measure	Calcium Hydroxylapatite n=19 Participants Subject will be treated at baseline and, if needed, at 2 weeks. Calcium hydroxylapatite: Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
Self-esteem	8.105 units on a scale Interval 7.0 to 9.0

PRIMARY outcome

Timeframe: 2 weeks

Self-esteem change will be determined by patient self-evaluation using the Heatherton \& Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. Self-esteem change will be determined by patient self-evaluation using the Heatherton \& Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. A 20-item scale that measures a participant's self-esteem at a given point in time. The 20 items are subdivided into 3 components of self-esteem: (1) performance self-esteem, social self-esteem, and appearance self-esteem. All items are answered using a 5-point scale (1= not at all, 2= a little bit, 3= somewhat, 4= very much, 5= extremely). Scores range from 20-100. Scores closer to 100 indicate a more favorable outcome.

Outcome measures

Outcome measures
Measure	Calcium Hydroxylapatite n=19 Participants Subject will be treated at baseline and, if needed, at 2 weeks. Calcium hydroxylapatite: Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
Self-esteem	8.35 score on a scale Interval 7.55 to 9.35

SECONDARY outcome

Timeframe: baseline and 1 month post-OCR (averaged)

Each subject will complete a 10-point (1-Not at all to 10-Very Much) scale evaluating their own first impression at Baseline and 1-month post-OCR. First impression scores were recorded at baseline and 1-month post-OCR, and an average of the two scores were reported.

Outcome measures

Outcome measures
Measure	Calcium Hydroxylapatite n=19 Participants Subject will be treated at baseline and, if needed, at 2 weeks. Calcium hydroxylapatite: Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
Subject First Impression	7.35 score on a scale Interval 6.15 to 8.5

SECONDARY outcome

Timeframe: 1 month

Live subject malar deficiency severity will be rated by PI at Visits 1-4 according to the SOBER scale (Weeks 1-4 correspond to Visits 1-4). SOBER Scale (Solish Beer Remington Scale): is used to grade facial rhytids in the malar region. Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Extreme Grade 5: Extreme Scores closer to 1 is a more favorable outcome, while scores closer to 5 is a less favorable outcome

Outcome measures

Outcome measures
Measure	Calcium Hydroxylapatite n=19 Participants Subject will be treated at baseline and, if needed, at 2 weeks. Calcium hydroxylapatite: Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
Assessment of Malar Deficiency Visit 1	4.8 score on a scale Interval 4.1 to 5.0
Assessment of Malar Deficiency Visit 2	4.2 score on a scale Interval 3.8 to 4.5
Assessment of Malar Deficiency Visit 3	2.7 score on a scale Interval 2.3 to 3.1
Assessment of Malar Deficiency Visit 4	1.6 score on a scale Interval 1.2 to 1.9

SECONDARY outcome

Timeframe: 1 month

Investigator will complete GAIS (Global Aesthetic Improvement Scale) at Visits 2-4 comparing overall appearance of current visit's photo to baseline photo. Worse: -1 No Change: 0 Improved: 1 Much Improved: 2 Very Much Improved: 3

Outcome measures

Outcome measures
Measure	Calcium Hydroxylapatite n=19 Participants Subject will be treated at baseline and, if needed, at 2 weeks. Calcium hydroxylapatite: Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
Aesthetic Improvement Visit 4	2.5 score on a scale Interval 1.0 to 3.0
Aesthetic Improvement Visit 2	1.7 score on a scale Interval 1.0 to 3.0
Aesthetic Improvement Visit 3	1.9 score on a scale Interval 1.0 to 3.0

Adverse Events

Calcium Hydroxylapatite

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jack Arkins, Data Manager

DeNova Research

Phone: 312-335-2070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place