Injectable Filler for Cheek Flattening

NCT01225354 | Completed Phase 4 Results

• 1 other identifier: RAD-IMP-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  After the 1-month post optimal correction visit for 20 subjects (averaged)

• 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.

  1 month

• 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.

  2 weeks

Secondary Outcomes (3)

• Subject First Impression

  baseline and 1 month post-OCR (averaged)

• Assessment of Malar Deficiency

  1 month

• Aesthetic Improvement

  1 month

Study Arms (1)

Calcium hydroxylapatite

EXPERIMENTAL

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

Drug: Calcium hydroxylapatite

Interventions

Calcium hydroxylapatite DRUG

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

Also known as: Radiesse, CaHA

Calcium hydroxylapatite

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DeNova Research: lead
• Merz Aesthetics Inc.: collaborator

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Related Links

• DeNova Research

MeSH Terms

Interventions

Durapatite; Prolaryn Plus

Intervention Hierarchy (Ancestors)

Hydroxyapatites; Apatites; Calcium Phosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Calcium Compounds; Minerals; Phosphorus Compounds

Results Point of Contact

• Title: Jack Arkins, Data Manager
• Organization: DeNova Research

jack@drdayan.com

312-335-2070

Study Officials

• Steven H Dayan, MD

  DeNova Research/ Chicago Center for Facial Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 21, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 16, 2020
• Results First Posted: September 28, 2012

Record last verified: 2020-11

Locations

US (1)