Injectable Filler for Cheek Flattening
Condition: Malar Deficiency
Intervention: Calcium hydroxylapatite
Intervention description: Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
Intervention MeSH terms: Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cheek; Cheek flattening; Malar deficiency; Filler

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.
    

Eligibility criteria:

        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.