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New treatment option for Aesthetic Improvement of the Skin
Official title Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration
ClinicalTrials.gov ID: NCT07151859
What this study is testing
- What it's testing
- Adequate skin hydration is critical for maintaining healthy skin. Moreover, dehydration, together with reduction in cell renewal, loss of radiance, elasticity and firmness, is involved in skin aging.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Subject Informed consent form (ICF) signed;
- Female and male people aged 18-70 years;
- people desiring improvement of skin hydration in maximum 1 area of the face or desiring improvement of skin hydration of neck or décolleté.
- Healthy skin;
- Willingness to discontinue all dermatological treatment and procedures during the study;
You likely can't join if
- Other - different - clinical conditions of the skin (i.e. rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and...
- Infectious or inflammatory processes near the area of intervention;
- Presence of cutaneous disease on the tested area, as malformations and recurrent facial/labial herpes;
- Presence of tendon, bone or muscular implants near the area of intervention;
- Ongoing cutaneous allergies;
- Allergy or contraindications to device components;
See the full eligibility criteria
- Subject Informed consent form (ICF) signed;
- Female and male people aged 18-70 years;
- people desiring improvement of skin hydration in maximum 1 area of the face or desiring improvement of skin hydration of neck or décolleté.
- Healthy skin;
- Willingness to discontinue all dermatological treatment and procedures during the study;
- Willingness to follow all study procedures, including attending all site visits, tests and examinations;
- Agreeing to present at each study visit without face/neck/décolleté cosmetics;
- Accepting to not change their habits regarding food, physical activity, face/neck/décolleté cosmetics and cleansing products;
- Willingness to follow indications to avoid make-up in the 12 hours following the injection treatment and to avoid any prolonged exposure to the sun, UV rays and temperatures below 0°C, as well as any sauna or hammam...
- Skin phototype I-IV according to Fitzpatrick's classification.
- Other - different - clinical conditions of the skin (i.e. rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and diagnosticated cancer with/without ongoing antitumor therapy);
- Infectious or inflammatory processes near the area of intervention;
- Presence of cutaneous disease on the tested area, as malformations and recurrent facial/labial herpes;
- Presence of tendon, bone or muscular implants near the area of intervention;
- Ongoing cutaneous allergies;
- Allergy or contraindications to device components;
- Concomitant intake of anticoagulant or antiplatelet medications;
- people who have not followed a washout period of 2 weeks from topical corticosteroids, antibiotics, benzoyl-peroxide, azelaic acid, hydroxy acids, topical retinoids;
- Immune system illnesses/disease;
- Uncontrolled diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
- Treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin E), or drugs able to influence the test results in the investigator opinion, within 5 days prior to study inclusion;
- Known drug and/or alcohol abuse;
- Mental incapacity that precludes adequate understanding or cooperation;
- Any previous permanent and non-permanent cutaneous treatment for aesthetic correction (biomaterial implant, lifting, laser, botulinum toxin injections, chemical peeling, fillers) of the treated area within 6 months...
- Pregnancy or breastfeeding;
- Participation in another investigational study within 1 month prior to study inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.