Juvederm Voluma® XC for the Treatment of Hypoplastic Chin

NCT02330016 | Unknown

• 1 other identifier: VolumaChin-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center study of the safety and efficacy of Juvedérm Voluma for the treatment of hypognathism. Each qualified subject will undergo treatment with Juvedérm Voluma in the anterior and lateral chin for volume correction. Prior to treatment, the principal investigator will evaluate the severity of chin recession using a 90 degree image and a goniometer to measure the angle from the glabella to the chin. Subjects will be eligible for injection if the angle measures between 145 - 160 degrees. Facial digital photography will be captured prior to treatment and at each subsequent visit. The subject will complete a safety and injection site response (ISR) diary beginning on the evening of treatment. The subject will return at Day 3 and Day 14 after initial treatment, at which time the subject will undergo photography and the investigator will rate treatment improvement (GAIS). An independent image analysis technician will assess the degree of correction. The investigator will evaluate the treatment area for any adverse events (AEs). The subject will return 30 days after initial treatment, and the principal investigator will determine if a touch-up treatment is warranted. If deemed necessary, a touch-up treatment may be administered. Facial digital photography will be captured prior to treatment and following treatment. The subject will return 3 days after the touch-up to undergo digital photography and for the principal investigator to assess safety/improvement. After initial or touch-up treatment, whichever is last, routine follow-up visits for safety and effectiveness will occur at 1 (30 days), 2, 4, 6, 9 (telephone call only) and 12 months. At all follow-up visits, facial digital photography will be captured and the investigator will rate treatment improvement (GAIS).. At screening and at Months 1, 2, 4, 6 and month 12 subjects will complete the satisfaction of face overall module of the FACE-Q questionnaire. The goal of this study will be to assess the feasibility of Voluma XC for the treatment of hypoplastic chins

Conditions

Mandibular Hypoplasia

Outcome Measures

Primary Outcomes (1)

• Primary outcome will be a change in the facial angle as measured by a blinded facial image analysis technician.

  12 months

Secondary Outcomes (1)

• Evaluation of the patient's self image using the satisfaction with lower face and jawline, satisfaction of chin, and appraisal of area under chin modules of the FACE-Q questionnaire.

  12 months

Study Arms (1)

Voluma XC

EXPERIMENTAL

Injections of Voluma will be accomplished using a serial puncture and fanning technique with the needle inserted to the periosteal plane as well as in the subcutaneous plane. The treatment area will include the medial and lateral chin as defined: lateral chin landmark is the depressor anguli oris.

Device: Voluma XC

Interventions

Voluma XC DEVICE

Voluma XC

Voluma XC

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 22 years and above Has moderate to severe chin hypognathism Moderate to severe hypognathism 145-160 degrees as measured with goniometer by principal investigator at screening visit. All other measurements will be performed by a blinded Canfield facial image analysis technician. Written informed consent has been obtained Written Authorization for Use and Release of Health and Research Study Information has been obtained Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable. Ability to follow study instructions and likely to complete all required visits If the subject is a female of childbearing potential (sexually active and not sterile, surgically sterilized, or postmenopausal with no menses for at least 1 year), have a urine pregnancy test evaluated as negative at randomization, have used contraception for at least 30 days prior to enrollment, and agree to use a reliable method of contraception for the duration of the study. Subject agrees to abstain from any treatment to the lower 1/3 of the face including botulinum toxins, hyaluronic acid fillers, cosmetic surgery, laser/light therapy, chemical peels, etc.

You may not qualify if:

• Uncontrolled systemic disease. Severe cardiovascular disease. Known allergy or sensitivity to the study medication(s) or its components Females who are pregnant, nursing, or planning a pregnancy. Pregnancies that occur will be followed by the sponsor until delivery or termination. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study. Previous treatment to the glabella, philtrum or chin with hyaluronic acid fillers or semi-permanent filler (i.e. Radiesse) in the past 12 months and for the duration of the study Any use of permanent filler materials such as Artefill or silicone in the face. Subjects planning a facial cosmetic procedure during the study period or with prior cosmetic procedures (i.e. surgery) in the treatment area or visible scars that may affect the evaluation.
• Subjects will need to be on the same facial product regimen for 90 days and no topical anti-wrinkle products on the chin. Had received (or was planning to receive) anti-coagulation medication(e.g., warfarin) from 10 days pre to 3 days post-injection. Planned rhinoplasty Any subjects with volume deficit due to trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disese, or HIV-related disease. Infection or dermatoses at the injection site.
• Evidence of recent alcohol or drug abuse. Medical and/or psychiatric problems that is severe enough to interfere with the study results.
• Known bleeding disorder or is receiving medication that will likely increase the risk of bleeding as the result of injection. Has facial hair that would interfere with evaluation and treatment of the chin area Has a tendency to develop hypertrophic scarring Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthestics), HA products, or Streptococcal protein.
• Has porphyria Has an active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the lower face/jawline or chin area.
• Subject has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Sponsors & Collaborators

• Kenneth Beer: lead
• Allergan: collaborator

Study Sites (1)

Kenneth R. Beer, M.D., PA

West Palm Beach, Florida, 33401, United States

RECRUITING

Related Links

• practice webste

MeSH Terms

Conditions

Micrognathism

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kenneth Beer, M.D.

  Beer, Kenneth R., M.D., PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Dunn, R.N., BSN

CONTACT

561-655-9055; mdunn@palmbeachcosmetic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: January 1, 2015
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

US (1)