Status:
ACTIVE_NOT_RECRUITING
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Lead Sponsor:
Semikal Technology
Conditions:
Facial Aging
Skin Rejuvenation
Eligibility:
All Genders
18+ years
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 photograph...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07160777
Start Date
November 1 2024
End Date
December 31 2025
Last Update
September 8 2025
Active Locations (1)
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1
Akdeniz University Hospital Dermatology Department Cosmetology Clinic
Antalya, Turkey (Türkiye), 07100