Injectable Filler for Cheek Flattening

NCT ID: NCT01225354

Last Updated: 2020-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-10-31

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.

Conditions

Malar Deficiency

Keywords

Cheek; Cheek flattening; Malar deficiency; Filler

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Calcium hydroxylapatite

Subject will be treated at baseline and, if needed, at 2 weeks.

Group Type: EXPERIMENTAL

Calcium hydroxylapatite

Intervention Type: DRUG

Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.

Interventions

Calcium hydroxylapatite

Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.

Intervention Type: DRUG

Other Intervention Names

Radiesse; CaHA

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merz Aesthetics Inc.

INDUSTRY

Sponsor Role: collaborator

DeNova Research

OTHER

Sponsor Role: lead

Responsible Party

Steven H. Dayan

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven H Dayan, MD

Role: PRINCIPAL_INVESTIGATOR

DeNova Research/ Chicago Center for Facial Plastic Surgery

Locations

DeNova Research

Chicago, Illinois, United States

Countries

United States

Related Links

http://www.denovaresearch.com

DeNova Research

Other Identifiers

RAD-IMP-001

Identifier Type: -

Identifier Source: org_study_id