Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation

NCT07160777 | Active Not Recruiting

• 1 other identifier: SEMDERMA
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to verify safety and performance of Semical dermal fillers according to real-world data.

Conditions

Facial Aging; Skin Rejuvenation; Volume Defects in the Mid-face; Lip Augmentation and Correction of Perioral Rhytids; Marionette Lines; Nasolabial Fold Correction; Periorbital Wrinkles; Facial Wrinkles and Rhytides Reduction

Keywords

SEMDERMA; dermal filler; mesolifter; wrinkle correction; lip augmentation

Outcome Measures

Primary Outcomes (1)

• GAIS

  Change of Global Aesthetic Improvement Scale evaluated by patient, investigator and independent rater

  From baseline to immediately after injection, 3 months, 6 months, 9 months

Secondary Outcomes (5)

• WSRS

  From baseline to immediately after injection, 3 months, 6 months

• Satisfaction of volunteer

  From baseline to immediately after injection, 3 montsh, 6 months

• Ease of use

  From baseline to immediately after injection, 3 months, 6 months

• Injection pain

  During injection and 15 minutes after injection

• Adverse events

  throughout the entire study

Study Arms (2)

Cross-linked Hyaluronic Acid Dermal Filler

Products: Semical Dermal Filler- Fine Semical Dermal Filler - Plus Semical Dermal Filler - Ultra Cross-linked hyaluronic acid injection for wrinkle correction and/or reshaping of nasolabial folds, marionette lines, crow's feet, perioral lines, periorbital lines, cheek and lip augmentation

Device: cross-linked hyaluronic acid

Stabilized Non Cross-linked Hyaluronic Acid Mesolifter

Semical Mesolifter injection for rejuvenation and revitalization of facial skin

Device: Mesolifter

Interventions

cross-linked hyaluronic acid DEVICE

Semical Dermal Filler Fine Semical Dermal Filler Plus Semical Dermal Filler Ultra

Also known as: Dermal Filler, Hyaluronic acid dermal filler

Cross-linked Hyaluronic Acid Dermal Filler

Mesolifter DEVICE

Stabilized hyaluronic acid with NONASEM Technology. Application with Multi-Aesthetic Point Technique (MAPs)

Also known as: Skin booster

Stabilized Non Cross-linked Hyaluronic Acid Mesolifter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female and male volunteers aged 18 and over who had facial filler application with Semical brand hyaluronic acid dermal fillers at the Akdeniz University Hospital Cosmetology Polyclinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semikal Technology: lead

Study Sites (1)

Akdeniz University Hospital Dermatology Department Cosmetology Clinic

Antalya, 07100, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 8, 2025
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)