Overview

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

Status:
Not yet recruiting
Trial end date:
2022-05-02
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to quantify the psychological, social, and emotional impact of comprehensive aesthetic treatment with a portfolio of Allergan products by measuring the change in subject's satisfaction with facial appearance from baseline (before any treatment) to the final study visit
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
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

- 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

Exclusion Criteria:

- 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

- Systemic retinoid therapy within one year prior to study enrollment

- History or current symptoms of dysphagia

- 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

- Profound atrophy/excessive weakness of muscles in target areas of injection

- 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)

- Very thin skin in the mid-facial region

- 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

- Subjects with neuromuscular disorders including generalized muscle weakness, diplopia,
ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise

- Subjects with a history of allergies