Clinical trial NCT06997380: Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel
Official title: Assessment of the Safety and Efficacy of the DensiStim Medical Device, an Injectable Liposomal Gel, in Adult Participants
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Skin Aging
Skin Wrinkling
Facial Skin Laxity
Facial Wrinkles
Keywords: hyaluronic acid
skin biostimulation
intradermal injection
facial skin rejuvenation
dry skin
thin skin
skin rejuvenation
Lead sponsor: Biovico Sp. z o.o.
Sponsor class: INDUSTRY
First posted: 2025-05-30
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Female sex;
2. Age over 18 years;
3. Caucasian race;
4. Thin, dry, and sagging facial skin;
5. Signing an informed consent form;
6. Commitment to refrain from undergoing facial therapies that may affect skin condition;
7. Negative pregnancy test result and commitment to use a contraceptve method;

Exclusion Criteria:

1. Scars, birthmarks, or tattoos on the face that could interfere with the assessment of skin condition;
2. Presence of open wounds, ulcers, active infections, or other significant skin damage at the planned injection site;
3. Receipt of intradermal facial injections with native hyaluronic acid, platelet-rich plasma, or other injectable therapies within 6 months prior to study initiation;
4. Receipt of intradermal facial injections with slowly absorbable or non-absorbable filler products within 12 months prior to study initiation;
5. Known hypersensitivity to any component of the investigational product;
6. Dermatitis or dermatological disease of inflammatory and/or infectious nature at the planned injection site;
7. History of cancer, autoimmune disease, or immunodeficiency;
8. Use of medications affecting blood coagulation;
9. Use of topical antihistamines, corticosteroids, or retinoids on the face within 4 weeks prior to the study;
10. Pregnancy or breastfeeding;
11. Participation or planned participation in other clinical trials;

Primary outcomes:
measure: Change in facial skin thickness
timeFrame: No later than 8 weeks after the last injection
Secondary outcomes:
measure: Change in facial skin thickness based on ultrasound measurements, comparison between visits
timeFrame: baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment
measure: Change in facial skin thickness based on ultrasound measurements, comparison between study arms
timeFrame: baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment
measure: Change in facial skin parameters based on multispectral skin analysis
timeFrame: baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment
measure: Change in aesthetic improvement and psychological well-being scores, assessed by participants
timeFrame: baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment
measure: Change in aesthetic improvement scores, assessed by the Investigator
timeFrame: baseline, 1 month after first injection, 1 month after second injection, 1 month after third injection and 2 months post-treatment
measure: Percentage of participants satisfied with the results of the injections
timeFrame: 1 months and 2 months post-treatment
measure: Post-injection sensation scores, assessed by participants using the Numeric Rating Scale Questionnaire
timeFrame: after first injection, after second injection, after third injection
measure: Incidence of adverse events by event type
timeFrame: From enrollment to 2 months after the last injection
measure: Percentage of participants who discontinued treatment due to adverse events
timeFrame: From enrollment to 2 months after the last injection
Other outcomes:
Locations:
city: Kowale
country: Poland
facility: Dr Agnieszka Sirocka - Medycyna Estetyczna
Study officials:
name: Agnieszka Sirocka
role: PRINCIPAL_INVESTIGATOR
References: