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Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment

NCT04609020 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-06-17

Study results available
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Summary

The primary objective of this study is to quantify the psychological, social, and emotional impact of comprehensive aesthetic treatment with a portfolio of the Sponsor's products by measuring the change in subject's satisfaction with facial appearance from baseline (before any treatment) to the final study visit

Conditions

  • Facial Rhytides
  • Skin Folds
  • Loss of Volume and Skin Quality

Interventions

DEVICE

JUVÉDERM

JUVÉDERM VOLBELLA with Lidocaine Treatment of any fine lines and medium-sized skin depressions. Can also be used for enhancement and pouting of the lips to correct structural defects such as asymmetry, contour deformities, volume loss. JUVÉDERM VOLIFT with Lidocaine Intended for the treatment of any deep skin depressions due to conditions such as premature aging. Can also be used for face contouring and volume restoration to correct facial structural defects such as asymmetry, contour deformities, volume loss in the lips, cheeks, chin, lower face. JUVÉDERM VOLUMA with Lidocaine Intended to restore volume of the face JUVÉDERM VOLITE with Lidocaine Intended for treatment, by filling, of superficial cutaneous depressions such as fine lines and for additional improvement of skin quality attributes such as hydration and elasticity. JUVÉDERM VOLUX with Lidocaine Intended to restore and generate facial volume in chin and mandible areas

DRUG

BOTOX

Indicated for the treatment of hyperkinetic facial lines.

DEVICE

HArmonyCA Lidocaine

HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • ALLERGAN INC. · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2024-05-10
Completion
2024-05-10
FDA Drug
Yes
FDA Device
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

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 NCT04609020 on ClinicalTrials.gov