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

NCT03712449 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: CMO-MA-FAS-0579
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Rasch-transformed Score of FACE-Q Satisfaction With Facial Appearance Overall Scale to End of Study

  The participant assessed satisfaction using the 10 items on the FACE-Q: Satisfaction with Facial Appearance questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed scale score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.

  Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

Secondary Outcomes (10)

• Change From Baseline in Participant's Assessment of Expectations of Life Change as Measured by Rasch-transformed Score of FACE-Q Expectations Scale to End of Study

  Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

• Change From Baseline in Participant's Assessment of Age-related Facial Appearance as Measured by Rasch-transformed Score of FACE-Q Aging Appraisal Scale to End of Study

  Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

• Change From Baseline in Participant's Assessment of Psychological Well-being as Measured by Rasch-transformed Score of FACE-Q Psychological Function Scale to End of Study

  Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

• Change From Baseline in Participant's Assessment of Social Function as Measured by Rasch-transformed Score of FACE-Q Social Function Scale to End of Study

  Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

• Change From Baseline in Participant's Assessment of Overall Satisfaction With Skin as Measured by Rasch-transformed Score of FACE-Q Satisfaction With Skin Scale to End of Study

  Baseline (Prior to Treatment) to End of Study (BELKYRA Treatment: Up to Month 11; Non-BELKYRA Treatment: Up to Month 5)

Study Arms (2)

BELKYRA Treatment

EXPERIMENTAL

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.

Device: JUVÉDERM®; Drug: BOTOX Cosmetic®; Drug: BELKYRA®; Other: SkinMedica

Non-BELKYRA Treatment

EXPERIMENTAL

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.

Device: JUVÉDERM®; Drug: BOTOX Cosmetic®; Other: SkinMedica

Interventions

JUVÉDERM® 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).

BELKYRA Treatment; Non-BELKYRA Treatment

BOTOX Cosmetic® 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 Treatment; Non-BELKYRA Treatment

BELKYRA® DRUG

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

BELKYRA Treatment

SkinMedica 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).

BELKYRA Treatment; Non-BELKYRA Treatment

Eligibility Criteria

• Age: 30 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (7)

Carruthers & Humphrey Cosmetic Dermatology

Vancouver, British Columbia, BC V5Z 4E1, Canada

Location

Shannon Humphrey

Vancouver, British Columbia, BC V5Z 4E1, Canada

Location

Project Skin MD Vancouver

Vancouver, British Columbia, BC V6H 1K9, Canada

Location

Pacific Derm

Vancouver, British Columbia, BC V6H 4E1, Canada

Location

Dermetics

Burlington, Ontario, ON L7N 3N2, Canada

Location

Dr Nowell Solish

Toronto, Ontario, ON M5R 3N8, Canada

Location

Bertucci MedSpa

Woodbridge, Ontario, ON L4L 8E2, Canada

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: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Sara Sangha

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: January 22, 2019
• Primary Completion: July 29, 2020
• Study Completion: July 29, 2020
• Last Updated: October 31, 2023
• Results First Posted: August 25, 2021

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)