Clinical trial NCT01225354: Injectable Filler for Cheek Flattening
Official title: An Open-label, Prospective, Postmarket Study to Assess Altering First Impressions and Self-esteem Following Radiesse® Injections.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malar Deficiency
Keywords: Cheek
Cheek flattening
Malar deficiency
Filler
Lead sponsor: DeNova Research
Sponsor class: OTHER
Collaborators: name: Merz Aesthetics Inc.
First posted: 2010-10-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Blinded Evaluations of First Impression
timeFrame: After the 1-month post optimal correction visit for 20 subjects (averaged)
measure: Self-esteem
timeFrame: 1 month
measure: Self-esteem
timeFrame: 2 weeks
Secondary outcomes:
measure: Subject First Impression
timeFrame: baseline and 1 month post-OCR (averaged)
measure: Assessment of Malar Deficiency
timeFrame: 1 month
measure: Aesthetic Improvement
timeFrame: 1 month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: DeNova Research/ Chicago Center for Facial Plastic Surgery
name: Steven H Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References: