Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07160777

Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akdeniz University Hospital Dermatology Department Cosmetology Clinic

Antalya, 07100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cross-linked hyaluronic acid

Device

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

Other names: Dermal Filler, Hyaluronic acid dermal filler

Mesolifter

Device

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

Other names: Skin booster

Primary outcomes

  1. 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

Secondary outcomes

  1. WSRS

    Time frame: From baseline to immediately after injection, 3 months, 6 months

    Change of Wrinkle Severity Rating Scale (WSRS) evaluated by patient, investigator and independent rater

  2. Satisfaction of volunteer

    Time frame: From baseline to immediately after injection, 3 montsh, 6 months

    Evaluation of before and after results by visual analogue scale

  3. Ease of use

    Time frame: From baseline to immediately after injection, 3 months, 6 months

    Investigator's assessment for ease of use of the product

  4. Injection pain

    Time frame: During injection and 15 minutes after injection

    Pain perception with visual analogue scale (VAs) during and 15 minutes after injection

  5. Adverse events

    Time frame: throughout the entire study

    Tolerability of the application by evaluation of severity and intensity of the adverse events

Sponsors and collaborators

Lead sponsor

Semikal Technology

Industry

Registry information

Official study title

A Single Center Study Evaluating The Clinical Performance and Safety of Hyaluronic Acid-Based Implantable Dermal Fillers Applied to the Face

Acronym: SEMDERMA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.