A Study to Evaluate Participant Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment

NCT ID: NCT03712449

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2020-07-29

Brief Summary

The objective of this study is to quantify the psychological and emotional impact of comprehensive aesthetic treatment with a portfolio of Allergan products by measuring the change in participant's satisfaction with facial appearance from baseline to the final study visit.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BELKYRA Treatment

BELKYRA was injected into the subcutaneous fat for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose did not exceed 100 milligrams (mg) [10 milliliters (mL)] in a single treatment.

SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11.

Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8. The volume of filler injected at initial and touch-up treatments was determined by the investigator.

BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 9 and Month 10.

Group Type: EXPERIMENTAL

JUVÉDERM®

Intervention Type: DEVICE

Facial filler injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8 (BELKYRA Treatment) and Month 0 to Month 2 (Non-BELKYRA Treatment).

BOTOX Cosmetic®

Intervention Type: DRUG

BOTOX Cosmetic, 20 U to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U injected to forehead lines at Month 9 and Month 10 (BELKYRA Treatment) and at Month 3 and Month 4 (Non-BELKYRA Treatment).

BELKYRA®

Intervention Type: DRUG

BELKYRA, subcutaneous injection for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose = 100 mg (10mL).

SkinMedica

Intervention Type: OTHER

SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11 (BELKYRA Treatment) and Month 0 to Month 5 (Non-BELKYRA Treatment).

Non-BELKYRA Treatment

Participants who did not receive BELKYRA.

SkinMedica products: (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 0 to Month 5.

Facial filler injectable treatment (JUVÉDERM VOLBELLA with Lidocaine and/or JUVÉDERM VOLIFT with Lidocaine and/or JUVÉDERM VOLUMA with Lidocaine and/or JUVÉDERM VOLITE with Lidocaine) from Month 0 to Month 2. The volume of filler injected at initial and touch-up treatments was determined by the investigator.

BOTOX Cosmetic 20 units (U) to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U total injected to forehead lines at Month 3 and Month 4.

Group Type: EXPERIMENTAL

JUVÉDERM®

Intervention Type: DEVICE

Facial filler injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8 (BELKYRA Treatment) and Month 0 to Month 2 (Non-BELKYRA Treatment).

BOTOX Cosmetic®

Intervention Type: DRUG

BOTOX Cosmetic, 20 U to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U injected to forehead lines at Month 9 and Month 10 (BELKYRA Treatment) and at Month 3 and Month 4 (Non-BELKYRA Treatment).

SkinMedica

Intervention Type: OTHER

SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11 (BELKYRA Treatment) and Month 0 to Month 5 (Non-BELKYRA Treatment).

Interventions

JUVÉDERM®

Facial filler injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8 (BELKYRA Treatment) and Month 0 to Month 2 (Non-BELKYRA Treatment).

Intervention Type: DEVICE

BOTOX Cosmetic®

BOTOX Cosmetic, 20 U to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U injected to forehead lines at Month 9 and Month 10 (BELKYRA Treatment) and at Month 3 and Month 4 (Non-BELKYRA Treatment).

Intervention Type: DRUG

BELKYRA®

BELKYRA, subcutaneous injection for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose = 100 mg (10mL).

Intervention Type: DRUG

SkinMedica

SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11 (BELKYRA Treatment) and Month 0 to Month 5 (Non-BELKYRA Treatment).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• History of any intervention to treat submental fat (SMF) (e.g. liposuction, surgery, or lipolytic agents)
• History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
• An anatomical feature (e.g. predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands) for which reduction in SMF may, in the judgment of the investigator, result in an aesthetically unacceptable outcome
• Evidence of any cause of enlargement in the submental area (e.g. thyroid enlargement, cervical adenopathy, ptotic submandibular gland) other than localized SMF
• Any medical condition (e.g. respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the participant's ability to undergo study procedures or give informed consent
• Body mass index (BMI) > 30
• 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 Cosmetic® or treatment with any other botulinum toxin product for any condition at any time prior to entry in the study
• Received (or is planning to receive) anticoagulation, 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
• Received temporary or semi-permanent facial or neck dermal filler injections (e.g. hyaluronic acid (HA), calcium hydroxylapatite, L-polylactic acid) at any time prior to entry in the study
• 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
• Began use of any new over-the-counter (OTC) or prescription, oral or topical, antiwrinkle products on the facial area within 90 days prior to enrollment or planning to begin use of such products at any time during the study
• Lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
• Received any investigational product within 60 days prior to study enrollment or planning to participate in another investigation during the course of this study
• An employee (or a relative of an employee) of the investigators, Allergan, or representative of Allergan
• Current use of oral corticosteroids
• Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin, ibuprofen) with the exception of a daily low dose of aspirin, 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 participants 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
• Systemic retinoid therapy within one year prior to study enrollment
• Medical condition that may increase the risk of exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function
• Current use of aminoglycoside antibiotics, curare-like agents, or agents that might interfere with neuromuscular (skeletal) function
• History of facial nerve palsy
• Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
• Tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads, i.e., significant convexity or projection from the infraorbital fat pads
• Mid-face volume deficit due to congenital defect, 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 disease, or human immunodeficiency virus-related disease
• Undergone oral surgery or other dental procedures (e.g. tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study
• Participants with neuromuscular disorders including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise
• Participants with a history of allergies or hypersensitivity to HA or lidocaine

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Sangha

Role: STUDY_DIRECTOR

Allergan

Locations

Carruthers & Humphrey Cosmetic Dermatology

Vancouver, British Columbia, Canada

Shannon Humphrey

Vancouver, British Columbia, Canada

Project Skin MD Vancouver

Vancouver, British Columbia, Canada

Pacific Derm

Vancouver, British Columbia, Canada

Dermetics

Burlington, Ontario, Canada

Dr Nowell Solish

Toronto, Ontario, Canada

Bertucci MedSpa

Woodbridge, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CMO-MA-FAS-0579

Identifier Type: -

Identifier Source: org_study_id