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

NCT04609020 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: CMO-MA-FAS-0580
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale.

  The FACE-Q questionnaire focuses on patient's satisfaction with facial appearance at the final study visit compared to before starting study treatment and is a 10- item questionnaire. Overall scores range from 0 to 100 with higher scores representing higher satisfaction.

  Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

Secondary Outcomes (8)

• Change From Baseline in the FACE-Q Aging Appraisal

  Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

• Change From Baseline in the Rasch-transformed Score of the FACE-Q Psychological Function Scale

  Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

• Change From Baseline in the Rasch-transformed Score of the FACE-Q Social Function Scale

  Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

• Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Skin

  Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

• Change From Baseline Self-Perception of Age

  Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)

Study Arms (1)

HArmonyCA, Juvederm, BOTOX

EXPERIMENTAL

All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit.

Device: JUVÉDERM; Drug: BOTOX; Device: HArmonyCA Lidocaine

Interventions

JUVÉDERM DEVICE

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

HArmonyCA, Juvederm, BOTOX

BOTOX DRUG

Indicated for the treatment of hyperkinetic facial lines.

HArmonyCA, Juvederm, BOTOX

HArmonyCA Lidocaine DEVICE

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

HArmonyCA, Juvederm, BOTOX

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not related to the study
• Women of childbearing potential must have a negative urine pregnancy test before each injectable treatment and practice a reliable method of contraception throughout the study
• Willing to avoid direct and prolonged sun exposure to the facial skin, which includes tanning beds, for the duration of the study
• Must qualify to receive BOTOX treatments, in at least one area, as per the approved Product Monograph including treatment of hyperkinetic lines for the glabellar, crow's feet, and forehead lines:
• Glabellar injection: glabellar rhytides characterized as moderate or severe during maximum muscle contraction on the evaluation of the facial wrinkle scale (FWS)
• CFLs characterized as 2 (moderate) or 3 (severe) during maximum smile on the evaluation of the FWS
• Forehead lines (FHLs) of moderate to 3 severe rating at maximum eyebrow elevation as assessed using the FWS

You may not qualify if:

• Body mass index (BMI) \> 30 kg/m2
• Known allergy or sensitivity to the study products or their components
• Pregnant, lactating, or planning to become pregnant at any time during the study
• Received BOTOX or treatment with any other botulinum toxin product for any condition within 6 months before enrollment
• Received (or is planning to receive) anti-coagulation, antiplatelet or thrombolytic medications (e.g., warfarin) or other substances known to increase coagulation time from 10 days prior to injection and up to 3 days post-injection
• Undergone plastic surgery of the face and/or neck, tissue grafting, or tissue augmentation with silicone, fat, or other permanent dermal fillers, or be planning to undergo any of these procedures at any time during the study
• Has undergone temporary or semi-permanent facial or neck dermal filler treatment (e.g., hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid) within 12 months before enrollment
• Received mesotherapy, skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face or neck within 6 months prior to study enrollment
• Marked facial asymmetry, brow or eyelid ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen the resting GLs and CFLs/facial rhytides by physically spreading them apart
• Lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
• At any proposed injection site, presence of inflammation, infection at any injection site or systemic infection (study entry may be postponed until one week following recovery), noticeable acne scarring, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated
• Received any investigational product within 60 days prior to study enrollment or planning to participate in another investigation during the course of this study
• Current use of oral corticosteroids
• Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen), from 10 days prior to injection up to 3 days post-injection
• Prescription topical retinoid therapy and/or topical hormone cream applied to the face, for potential subjects who have not been on a consistent dose regimen for at least 6 months prior to enrollment and who are unable to maintain regimen for the study

Sponsors & Collaborators

• Allergan: lead

Study Sites (6)

Hospital Regional da Asa Norte - Brasilia /ID# 239161

Brasília, Federal District, 70710-100, Brazil

Location

Hospital do Servidor Publico Municipal - Sao Paulo /ID# 239165

Niterói, Rio de Janeiro, 24230-052, Brazil

Location

Universidade de Sao Paulo - Sao Paulo /ID# 239163

Rio de Janeiro, 22440-032, Brazil

Location

Dermick Clinica de Dermatologia - Niteroi/Rio de Janeiro /ID# 239166

São Paulo, 04004-030, Brazil

Location

BRAVOMED Dermatology - Rio de Janeiro /ID# 239160

São Paulo, 04023-062, Brazil

Location

Universidade Federal de Sao Paulo - Sao Paulo /ID# 239156

São Paulo, 05005-001, Brazil

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: ABBVIE CALL CENTER
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

844-663-3742

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 30, 2020
• Study Start: February 15, 2023
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

BR (6)