Eligibility |
Inclusion Criteria:
1. At the time of consent, male and female subjects 18 years of age and older.
2. Patients with established chin retrusion at Baseline (a score of mild, moderate, and
severe severity on the Galderma Chin Retrusion Scale).
3. Accepted the obligation not to receive any other facial procedures throughout the
study duration.
4. Understood and accepted the obligation and would be logistically able to appear for
all scheduled follow-up visits.
5. No previous lower face fillers for 12 months prior to this study.
6. Capable of providing informed consent.
Exclusion Criteria:
1. Patients without chin retrusion at Baseline, per the Galderma Chin Retrusion Scale.
2. Current Pregnancy or lactation [sexually active women of childbearing age must agree
to use medically acceptable methods of contraception for the duration of this study
(e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)].
3. Hypersensitivity to Restylane or Juvéderm products, hyaluronic acid filler or amide
local anesthetics.
4. Patients presenting with porphyria or any other liver diseases.
5. Inability to comply with follow-up and abstain from facial injections during the study
period.
6. Heavy smokers, classified as smoking more than 12 cigarettes per day.
7. History of severe or multiple allergies manifested by anaphylaxis since drug allergies
might preclude optimal management of complications.
8. Previous tissue revitalization therapy in the treatment area (i.e., the lower face)
within 6 months before treatment with laser or light, mesotherapy, radiofrequency,
ultrasound, cryotherapy, chemical peeling, or dermabrasion.
9. Previous facial surgery, including liposuction.
10. Lifetime history of permanent implants in the treatment region (i.e., the lower face)
11. Lifetime history of semi-permanent dermal fillers in the treatment region (i.e., the
lower face).
12. History or presence of any disease or lesion near or at the treatment area, including
inflammation, active or chronic infection, including in the mouth, dentals, head, and
neck region.
13. Active facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes zoster or
any other facial condition that may increase the risk of cutaneous penetration of
infective agents.
14. Scars, deformities, piercings, or tattoos in the treatment areas.
15. Facial cancer or precancer (e.g., actinic keratosis).
16. History of radiation therapy in the treatment area.
17. History of bleeding disorders, or treatment with thrombolytics, anticoagulants, or
inhibitors of platelet aggregation (e.g., Aspirin or other non-steroid
anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment.
18. Patients with immune disorders such as systemic lupus erythematosus, rheumatoid
arthritis, mixed connective tissue disease, and Hashimoto's thyroiditis, or subjects
using immunosuppressants.
19. Patients with a tendency to form hypertrophic or keloid scars, or any other healing
disorders.
20. Patients with a tendency to form post-inflammatory hyperpigmentation.
21. Patients with known hypersensitivity to lidocaine or agents structurally related to
amide type local anesthetics (e.g., certain anti-arrhythmics).
22. Patients administered dental block or topical administration of lidocaine within 2
weeks of treatment.
23. Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic
function or severe renal dysfunction.
24. Current remote infections (e.g., urinary tract, sinuses, intestinal tract, oral
cavity)
25. Planned dental procedures during the 2-week period before and after filler treatments,
including teeth cleaning, tooth extraction and gum grafts.
26. Planned COVID-19 vaccinations during the 2-week period before and after filler
treatments.
27. Lifetime history of cystic acne, due to increased risk of cyst development following
filler treatment.
|