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Juvederm Voluma® XC for the Treatment of Hypoplastic Chin

NCT02330016 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-06-18

No results posted yet for this study

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

Interventions

DEVICE

Voluma XC

Voluma XC

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Kenneth Beer

    lead INDIV

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-08-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02330016 on ClinicalTrials.gov