Injectable Filler for Cheek Flattening

This study has been completed.
Sponsor:
Collaborator:
Merz Aesthetics Inc.
Information provided by (Responsible Party):
Steven H. Dayan, DeNova Research
ClinicalTrials.gov Identifier:
NCT01225354
First received: October 19, 2010
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Malar Deficiency
Drug: Calcium hydroxylapatite
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Open-label, Prospective, Postmarket Study to Assess Altering First Impressions and Self-esteem Following Radiesse® Injections.

Resource links provided by NLM:


Further study details as provided by DeNova Research:

Primary Outcome Measures:
  • Blinded Evaluations of First Impression [ Time Frame: After the 1-month post optimal correction visit for subject 20 ] [ Designated as safety issue: No ]
    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 each of the 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria.

  • Self-esteem [ Time Frame: 1 month post-optimal cosmetic result ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks post optimal cosmetic result ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Subject First Impression [ Time Frame: baseline, Visit 2, Visit3, and Visit 4 ] [ Designated as safety issue: No ]
    Each subject will complete the 10-point (1-Not at all to 10-Very Much) evaluating their own first impression at Baseline, Visit 2 (if applicable), Visit 3, and Visit 4.

  • Assessment of Malar Deficiency [ Time Frame: Visit 1-4 ] [ Designated as safety issue: No ]
    Live subject malar deficiency severity will be rated by PI at Visits 1-4 according to the SOBER scale.

  • Aesthetic Improvement [ Time Frame: Visit 2-4 ] [ Designated as safety issue: No ]
    Subject and Investigator will complete GAIS at Visits 2-4 comparing overall appearance of current visit's photo to baseline photo


Enrollment: 20
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium hydroxylapatite
Subject will be treated at baseline and, if needed, at 2 weeks.
Drug: Calcium hydroxylapatite
Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
Other Names:
  • Radiesse
  • CaHA

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225354

Locations
United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
DeNova Research
Merz Aesthetics Inc.
Investigators
Principal Investigator: Steven H Dayan, MD DeNova Research/ Chicago Center for Facial Plastic Surgery
  More Information

Additional Information:
No publications provided

Responsible Party: Steven H. Dayan, Medical Director, DeNova Research
ClinicalTrials.gov Identifier: NCT01225354     History of Changes
Other Study ID Numbers: RAD-IMP-001
Study First Received: October 19, 2010
Results First Received: August 29, 2012
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by DeNova Research:
Cheek
Cheek flattening
Malar deficiency
Filler

ClinicalTrials.gov processed this record on October 19, 2014