Facial AgingSEMDERMANCT07160777
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
An observational study of Facial Aging and Skin Rejuvenation, run by Semikal Technology at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to verify safety and performance of Semical dermal fillers according to real-world data. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Aging, Skin Rejuvenation, Volume Defects in the Mid-face
- What is being tested?
- cross-linked hyaluronic acid and Mesolifter
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Hospital Dermatology Department Cosmetology Clinic
Antalya, 07100
About this study
Official title: A Single Center Study Evaluating The Clinical Performance and Safety of Hyaluronic Acid-Based Implantable Dermal Fillers Applied to the Face
The aim of the study is to verify safety and performance of Semical dermal fillers according to real-world data.
Read the 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.
- Conditions
- Facial Aging, Skin Rejuvenation, Volume Defects in the Mid-face, Lip Augmentation and Correction of Perioral Rhytids, Marionette Lines, Nasolabial Fold Correction
- Being tested
- cross-linked hyaluronic acid, Mesolifter
- Keywords
- SEMDERMA, dermal filler, mesolifter, wrinkle correction, lip augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-linked hyaluronic acidDevice
Also called Dermal Filler, Hyaluronic acid dermal filler
Semical Dermal Filler Fine Semical Dermal Filler Plus Semical Dermal Filler Ultra
MesolifterDevice
Also called Skin booster
Stabilized hyaluronic acid with NONASEM Technology. Application with Multi-Aesthetic Point Technique (MAPs)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: cross-linked hyaluronic acid | |
| Stabilized Non Cross-linked Hyaluronic Acid Mesolifter | Semical Mesolifter injection for rejuvenation and revitalization of facial skin Receives: Device: Mesolifter |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAIS
Change of Global Aesthetic Improvement Scale evaluated by patient, investigator and independent rater
Measured: From baseline to immediately after injection, 3 months, 6 months, 9 months
Secondary outcomes (5)
WSRS
Change of Wrinkle Severity Rating Scale (WSRS) evaluated by patient, investigator and independent rater
Measured: From baseline to immediately after injection, 3 months, 6 months
Satisfaction of volunteer
Evaluation of before and after results by visual analogue scale
Measured: From baseline to immediately after injection, 3 montsh, 6 months
Ease of use
Investigator's assessment for ease of use of the product
Measured: From baseline to immediately after injection, 3 months, 6 months
Injection pain
Pain perception with visual analogue scale (VAs) during and 15 minutes after injection
Measured: During injection and 15 minutes after injection
Adverse events
Tolerability of the application by evaluation of severity and intensity of the adverse events
Measured: throughout the entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semikal Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160777
- Sponsor's protocol ID
- SEMDERMA
- Acronym
- SEMDERMA
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed by local regulations
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Study Evaluating The Clinical Performance and Safety of Hyaluronic Acid-Based Implantable Dermal Fillers Applied to the Face
- ClinicalTrials.gov ID
- NCT07160777
- Acronym / sponsor ID
- SEMDERMA / SEMDERMA
- Conditions
- Facial Aging, Skin Rejuvenation, Volume Defects in the Mid-face, Lip Augmentation and Correction of Perioral Rhytids, Marionette Lines, Nasolabial Fold Correction
- Keywords
- SEMDERMA, dermal filler, mesolifter, wrinkle correction, lip augmentation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Semikal TechnologyIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-linked Hyaluronic Acid Dermal Filler | – | Device: cross-linked hyaluronic acidProducts: 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 |
| Stabilized Non Cross-linked Hyaluronic Acid Mesolifter | – | Device: MesolifterSemical Mesolifter injection for rejuvenation and revitalization of facial skin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cross-linked hyaluronic acidAlso: Dermal Filler, Hyaluronic acid dermal fillerSemical Dermal Filler Fine Semical Dermal Filler Plus Semical Dermal Filler Ultra | Device | Cross-linked Hyaluronic Acid Dermal Filler |
| MesolifterAlso: Skin boosterStabilized hyaluronic acid with NONASEM Technology. Application with Multi-Aesthetic Point Technique (MAPs) | Device | Stabilized Non Cross-linked Hyaluronic Acid Mesolifter |
Primary outcome
GAIS
Time frame: 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
5 secondary outcomes
WSRS
Time frame: From baseline to immediately after injection, 3 months, 6 months
Satisfaction of volunteer
Time frame: From baseline to immediately after injection, 3 montsh, 6 months
Ease of use
Time frame: From baseline to immediately after injection, 3 months, 6 months
Injection pain
Time frame: During injection and 15 minutes after injection
Adverse events
Time frame: throughout the entire study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No. Not allowed by local regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Aging and Skin Rejuvenation, run by Semikal Technology at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAIS (time frame: From baseline to immediately after injection, 3 months, 6 months, 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.