Assessment of the Safety and Efficacy of the DensiStim Medical Device, an Injectable Liposomal Gel, in Adult Participants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Biovico Sp. z o.o.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in facial skin thickness
Study Overview
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, dry, and sagging facial skin.
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 endpoint will be the change in facial skin thickness resulting from three administrations of the DensiStim product, assessed no later than 8 weeks after the last procedure, based on ultrasound (US) measurements. Ultrasound measurements will also be compared between visits and between study arms.
Changes in aesthetic improvement will be assessed by both the participant and the Investigator. The safety of the investigational medical device will also be evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
needle group
product administration using a needle
Intervention: Clinical assessment (Procedure)
needle group
product administration using a needle
Intervention: Ultrasound measurement (Procedure)
needle group
product administration using a needle
Intervention: Injection of the investigational product via needle (Device)
needle group
product administration using a needle
Intervention: Multispectral imaging (Procedure)
cannula group
product administration using a cannula
Intervention: Injection of the investigational product via cannula (Device)
cannula group
product administration using a cannula
Intervention: Clinical assessment (Procedure)
cannula group
product administration using a cannula
Intervention: Ultrasound measurement (Procedure)
cannula group
product administration using a cannula
Intervention: Multispectral imaging (Procedure)
Outcomes
Primary Outcomes
Change in facial skin thickness
Time Frame: No later than 8 weeks after the last injection
Change from baseline in facial skin thickness following three intradermal administrations of the DensiStim product, based on ultrasound measurements.
Secondary Outcomes
- Change in facial skin thickness based on ultrasound measurements, comparison between visits(baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment)
- Change in facial skin thickness based on ultrasound measurements, comparison between study arms(baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment)
- Change in facial skin parameters based on multispectral skin analysis(baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment)
- Change in aesthetic improvement and psychological well-being scores, assessed by participants(baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment)
- Change in aesthetic improvement scores, assessed by the Investigator(baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment)
- Percentage of participants satisfied with the results of the injections(1 months and 2 months post-treatment)
- Post-injection sensation scores, assessed by participants using the Numeric Rating Scale Questionnaire(after first injection, after second injection, after third injection)
- Incidence of adverse events by event type(From enrollment to 2 months after the last injection)
- Percentage of participants who discontinued treatment due to adverse events(From enrollment to 2 months after the last injection)