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Post-Market Clinical Study Evaluating Safety and Effectiveness of RRS4 HA Long Lasting for Facial Wrinkles and Skin Quality Improvement
Led by Skin Tech Pharma Group S.L.U. · Updated on 2026-05-22
207
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance and long-term safety of the CE-marked RRS4 HA Long Lasting device to treat skin photoaging, focusing on improving facial wrinkles and overall skin quality in healthy adults. The study aims to measure the proportion of participants who experience significant wrinkle improvement by two months and compare photodamage changes between treated individuals and an untreated control group. Participants will be randomly assigned in a 2:1 ratio to either receive the RRS4 HA Long Lasting treatment or no treatment. The treatment involves a single injection on Day 0, with a possible second touch-up injection on Day 30 if the investigator and participant agree that improvement is less than 1 point on the wrinkle scale. The control group will not receive any intervention. Throughout the study, participants will attend follow-up visits at baseline, 1, 2, 3, and 6 months to assess wrinkle severity, photodamage, skin texture, hydration, and overall aesthetic improvement. Satisfaction of both subjects and investigators will be recorded at six months. Researchers will also monitor the presence of the product in tissue at various time points up to 12 months, ensuring comprehensive evaluation of safety and effectiveness over time.
CONDITIONS
Brief Title
Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old
- Presence of moderate (grade 2) or severe (grade 3) wrinkles on both sides of the face as assessed by the SASSQ scale
- Mild to moderate photoaging according to the Alexiades-Armenakas scale
- Willing and able to provide written informed consent and attend follow-up visits
- Psychologically able to understand study information and consent
- Seeking correction of facial wrinkles and agrees with investigator's recommendation
- Agrees not to receive other facial wrinkle treatments during the study
- Able to follow study instructions and likely to complete all visits
- For females of childbearing potential: negative pregnancy tests and use of medically accepted contraception before and during the study
You will not qualify if you...
- Pregnant or breastfeeding women or planning pregnancy during the study
- Presence of scars, moles, tattoos, or other markings on the face interfering with evaluation
- Legal guardianship or deprived of freedom by legal decision
- Residence in social or sanitary establishments
- Participation in another research study or within one month exclusion period
- Long-term outdoor work or sun exposure after treatment
- Intention to start or continue weight-loss programs during the study
- Lack of understanding of post-treatment skin care including sun and heat avoidance
- Medical conditions that may affect study compliance or results, such as severe or progressive diseases
- History or presence of autoimmune disease, immune deficiency, connective tissue disorders, cancer, or use of immunomodulatory drugs
- Active inflammatory or infectious skin disorders near treatment area
- History of streptococcal disease with cardiac involvement
- Prone to inflammatory skin conditions or bleeding disorders
- Allergy or hypersensitivity to hyaluronic acid or device components
- History of keloids, hypertrophic scars, or significant skin pigmentation changes
- Participation in another clinical study within past 30 days
- Facial treatments like laser, dermabrasion, surgery, or peeling within past 6 months
- Facial injections with resorbable fillers within past 24 months
- Past injections with slowly resorbable or non-resorbable fillers
- Previous facial tensor thread treatments
- Current or planned dental procedures affecting facial observation
- History of surgical rhinoplasty
- Use of medications causing lipo-atrophy
- Use of aspirin, NSAIDs, antiplatelets, anticoagulants, or vitamin C within one week before inclusion or chronic anticoagulant use
- Use of topical or systemic antibiotics, antihistamines, immunosuppressors, corticosteroids, or retinoids within specified times before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants receive injections of RRS® HA Long Lasting to improve facial wrinkles and skin quality. Some participants may receive a single injection, while others may receive a second touch-up injection after 30 days if needed.
1 to 2 visits depending on treatment group
Duration - 6 months
Participants are assessed for wrinkle severity, photodamage, skin texture, hydration, aesthetic improvement, and satisfaction over a period of up to 6 months after treatment.
Visits at baseline, 1 month, 2 months, 3 months, and 6 months
Trial Site Locations
Total: 2 locations
1
Zurko Research, S.L.
Madrid, Madrid, Spain, 28023
Actively Recruiting
2
Ocean Clinic
Marbella, Málaga, Spain, 29601
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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