Malar Deficiency
Conditions
Keywords
Cheek, Cheek flattening, Malar deficiency, Filler
Brief summary
The purpose of this study is to determine if Radiesse injections to the cheeks result in an altered and improved first impression and self esteem.
Interventions
Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
Sponsors
Merz Aesthetics Inc.
DeNova Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Females between 30 and 65 years of age with Fitzpatrick Skin Color Types (I-VI). * Have bilateral, fully visible aging defects in the malar area, corresponding to a rating of moderate to severe on the SOBER scale. * Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. * Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history: * postmenopausal for at least 12 months prior to study drug administration * without a uterus and/or both ovaries * has had a bilateral tubal ligation for at least 6 months prior to study drug administration. * absence of an other physical condition according to the PI's discretion * Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup). * Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Exclusion criteria
* Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control. * Subjects with a known allergy or sensitivity to any component of the study medications or anesthesia. * Subjects who have had prior exposure to any calcium hydroxylapatite, or any other filler, injection for any purpose in the 12 months preceding study enrollment through the duration of the study (excluding study drug). * Subjects who have had a prior cosmetic procedure to improve malar eminence deficiency (i.e., rhytidectomy, lower eyelid surgery, cheek implants, CO2/erbium laser resurfacing, Thermage/Thermacool radiofrequency treatment) or who have visible scars that may affect evaluation of response and/or quality of photography. * Subjects who have had soft tissue augmentation of the malar area in the previous 6 months. * Permanent or semi-permanent dermal fillers in the malar area. * Ablative skin resurfacing on the malar area within the previous 6 months or during the study. * Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the malar area within 2 weeks prior to study participation or during the study. * Active infection in the malar area (e.g., acute acne lesions or ulcers). * Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin. * Current history of chronic drug or alcohol abuse. * History of autoimmune disease. * Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication. * Subjects who anticipate the need for surgery or overnight hospitalization during the study. * Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability. * Enrollment in any active study involving the use of investigational devices or drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blinded Evaluations of First Impression | 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. |
| Self-esteem | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject First Impression | 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. |
| Assessment of Malar Deficiency | 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 |
| Aesthetic Improvement | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Calcium Hydroxylapatite Subject will be treated at baseline and, if needed, at 2 weeks. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Calcium Hydroxylapatite |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 48.2 years STANDARD_DEVIATION 9.71 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Blinded Evaluations of First Impression
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.
Time frame: After the 1-month post optimal correction visit for 20 subjects (averaged)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Calcium Hydroxylapatite | Blinded Evaluations of First Impression | 7.35 score on a scale |
Primary
Self-esteem
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.
Time frame: 1 month
Population: All subjects completing indicated visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Calcium Hydroxylapatite | Self-esteem | 8.105 units on a scale |
Primary
Self-esteem
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Calcium Hydroxylapatite | Self-esteem | 8.35 score on a scale |
Secondary
Aesthetic Improvement
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
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Calcium Hydroxylapatite | Aesthetic Improvement | Visit 2 | 1.7 score on a scale |
| Calcium Hydroxylapatite | Aesthetic Improvement | Visit 3 | 1.9 score on a scale |
| Calcium Hydroxylapatite | Aesthetic Improvement | Visit 4 | 2.5 score on a scale |
Secondary
Assessment of Malar Deficiency
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
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Calcium Hydroxylapatite | Assessment of Malar Deficiency | Visit 1 | 4.8 score on a scale |
| Calcium Hydroxylapatite | Assessment of Malar Deficiency | Visit 2 | 4.2 score on a scale |
| Calcium Hydroxylapatite | Assessment of Malar Deficiency | Visit 3 | 2.7 score on a scale |
| Calcium Hydroxylapatite | Assessment of Malar Deficiency | Visit 4 | 1.6 score on a scale |
Secondary
Subject First Impression
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.
Time frame: baseline and 1 month post-OCR (averaged)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Calcium Hydroxylapatite | Subject First Impression | 7.35 score on a scale |