Facial Aging, Facial Wrinkles and Rhytides Reduction, Lip Augmentation and Correction of Perioral Rhytids, Marionette Lines, Nasolabial Fold Correction, Periorbital Wrinkles, Skin Rejuvenation, Volume Defects in the Mid-face
Conditions
Keywords
SEMDERMA, dermal filler, mesolifter, wrinkle correction, lip augmentation
Brief summary
The aim of the study is to verify safety and performance of Semical dermal fillers according to real-world data.
Detailed description
This study is a single-center, open label clinical follow-up study. The records of volunteers who were treated with Semical brand dermal fillers on the face at the research center and whose photographs are keps in the researcher's records will be evaluated retrospectively by the principle investigator and an independent evaluator. Volunteers who were used in accordance with the current intended use declared by the manufacturer of Semical Fine, Plus, Ultra Dermal Fillers and Mesolifter as applied in routine practice by the researcher may be included. The dermal filler application must have been applied to the necessary and determined facial areas, expectations, product safety requirements, and skin structure, with the technique deemed appropriate by the researcher. In order to obtain optimal aesthetic results, an optional touch-up application may have been made 4 weeks after the first application.
Interventions
Semical Dermal Filler Fine Semical Dermal Filler Plus Semical Dermal Filler Ultra
DEVICEMesolifter
Stabilized hyaluronic acid with NONASEM Technology. Application with Multi-Aesthetic Point Technique (MAPs)
Sponsors
Semikal Technology
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged greater than or equal to 18 years * Female or male * Volunteers in good general health * Volunteers with soft tissue deficits on mid-face that can be corrected with volume restoration * Volunteers who evaluated by investigator as suitable for hyaluronic acid filler applications on her/his lips, nasolabial folds, temporal, perioral, periocular areas * Individuas who have not filler, botulinum toxin, laser, chemical peeling or surgery in the 6 months before the Semical dermal filler application * No permanent or non-permanent asthetic applications (chemical peeling, dermabrasion, ablative laser application) non-invasive face-lift, botulinum toxin injections, mesotherapy or fat injections after or simultaneously with filler application * Volunteers who have not had non-resorbable filler applied before * Volunteers who have complete records regarding the criteria to be evaluated in the study * Volunteers who do not have heavy and misleading make-up in their before and after photos * Volunteers who have not made significant lifestyle changes (diet, physical activity, permanent make-up application) * No exposure to extreme temperatures such as sunlight, UV solarium, laser, extreme cold, sauna, Turkish baths * All Fitzpatrick skin types
Exclusion criteria
* Patients under 18 years of age * Presence of impairment of wound healing or blood flow * Known history of allergy to the study product (hyaluronic acid), local anesthetic used (lidocaine) or gran-positive streptococcal proteins * Presence or history of keloid formation tendency, hypertrophic scar, shromatosis or discoloration * Skin disease with pronounced skin pigmentation * Connective tissue disorders * Coagulation disorders * Existing inflammation / infection at the injection site * Frequently recurring facial / labial herpes * Permanent or semi-permanent tendon, bone and muscle implants near the area to be application * History of allergy in the mouth area * Active autoimmune disease or immunosuppressed individuals with immune system problems * Diabetes mellitus or uncontrolled systemic disease (endocrine, hepatic, renal, cardiac pulmonary or neurological disorders) * Volunteers with acute inflammatory conditions or infections, active herpes infection or history of chronic and recurrent infections * Concomitant medications that affect blood circulation (e.g. aspirin, NSAIDs, Vitamin E, topical and systemic corticosteroids, narcotic antidepressants, immunosuppressive drugs; excluding hormonal and contraceptive treatments started before 1 year) and medications and treatments have the potenrial to affect treatment aoutcomes according to the investigator's opinion * Known alcohol or drug abuse * Subjects who are pregnant or breasfeeding * Subjects who have received COVID-19 vaccination within 30 days before dermal filler application * Epilepsy or porphyria, congenital or idiopathic methemoglebinemia, or glucose-6-phosphate dehydrogenase deficiency * Analgesic dependence or need for continuous use * Syphilis or HIV infection * Subjects who have undergone medication or surgical treatments that may cause significant changes in body weight after dermal filler application (such as bariatric surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GAIS | From baseline to immediately after injection, 3 months, 6 months, 9 months | Change of Global Aesthetic Improvement Scale evaluated by patient, investigator and independent rater |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WSRS | From baseline to immediately after injection, 3 months, 6 months | Change of Wrinkle Severity Rating Scale (WSRS) evaluated by patient, investigator and independent rater |
| Satisfaction of volunteer | From baseline to immediately after injection, 3 montsh, 6 months | Evaluation of before and after results by visual analogue scale |
| Ease of use | From baseline to immediately after injection, 3 months, 6 months | Investigator's assessment for ease of use of the product |
| Injection pain | During injection and 15 minutes after injection | Pain perception with visual analogue scale (VAs) during and 15 minutes after injection |
| Adverse events | throughout the entire study | Tolerability of the application by evaluation of severity and intensity of the adverse events |
Countries
Turkey (Türkiye)
Outcome results
None listed