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Completed

NCT Number: NCT04414397

A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old

The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking correction of temple hollowing

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Key information

Conditions

Temple Hollowing

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 232706, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants in general good health
  • Participants seeking improvement of temple hollowing

Exclusion criteria

  • Temple hollowing due to trauma, congenital malformations, or lipodystrophy
  • Temporomandibular joint dysfunction or any other jaw issues
  • Recurrent temporal headaches such as temporal tendinitis migraine
  • Active autoimmune disease
  • History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
  • Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy)
  • Fat injection or permanent facial implants anywhere in the face
  • Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment
  • Temporary dermal filler injections above the subnasale within 24 months before enrollment
  • Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment
  • Botulinum toxin treatment above the subnasale within 6 months before enrollment
  • Females who are pregnant, nursing, or planning a pregnancy

Treatment and study plan

JUVÉDERM® VOLUMA® XC

Device

JUVÉDERM® VOLUMA® XC injectable gel

No-treatment control

Other

Participants received no treatment for 3 months during the Control Period.

Primary outcomes

  1. Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3

    Time frame: Baseline, Month 3 (Control Period)

    The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.

  2. Number of Participants With Adverse Events

    Time frame: From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product.

Secondary outcomes

  1. Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3

    Time frame: Month 3 (Control Period)

    The Evaluating Investigator assessed the participant's temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.

  2. Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3

    Time frame: Month 3 (Control Period)

    Participants assessed their temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.

  3. Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3

    Time frame: Baseline, Month 3 (Control Period)

    The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, and 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.

  4. Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire

    Time frame: Baseline, Month 3 (Control Period)

    The participants responded to each item on the FACE-Q Satisfaction with Temples questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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