Status:
ENROLLING_BY_INVITATION
Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel
Lead Sponsor:
Biovico Sp. z o.o.
Conditions:
Skin Aging
Skin Wrinkling
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the efficacy and safety of intradermal injections of the medical device - hyaluronic acid with the addition of lecithin - in a population of participants with thin...
Detailed Description
A total of 36 participants are planned to be enrolled in the study (18 in each group: Group 1 - product administration using a needle; Group 2 - product administration using a cannula). The primary e...
Eligibility Criteria
Inclusion
- Female sex;
- Age over 18 years;
- Caucasian race;
- Thin, dry, and sagging facial skin;
- Signing an informed consent form;
- Commitment to refrain from undergoing facial therapies that may affect skin condition;
- Negative pregnancy test result and commitment to use a contraceptve method;
Exclusion
- Scars, birthmarks, or tattoos on the face that could interfere with the assessment of skin condition;
- Presence of open wounds, ulcers, active infections, or other significant skin damage at the planned injection site;
- Receipt of intradermal facial injections with native hyaluronic acid, platelet-rich plasma, or other injectable therapies within 6 months prior to study initiation;
- Receipt of intradermal facial injections with slowly absorbable or non-absorbable filler products within 12 months prior to study initiation;
- Known hypersensitivity to any component of the investigational product;
- Dermatitis or dermatological disease of inflammatory and/or infectious nature at the planned injection site;
- History of cancer, autoimmune disease, or immunodeficiency;
- Use of medications affecting blood coagulation;
- Use of topical antihistamines, corticosteroids, or retinoids on the face within 4 weeks prior to the study;
- Pregnancy or breastfeeding;
- Participation or planned participation in other clinical trials;
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 23 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06997380
Start Date
May 23 2025
End Date
April 23 2026
Last Update
May 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr Agnieszka Sirocka - Medycyna Estetyczna
Kowale, Poland, 80-180