RRS HA Long Lasting for Wrinkle Reduction on Photoaged Facial Skin
Official title: Post-Market Interventional Clinical Investigation to Evaluate the Safety and Efficacy of RRS® HA Long Lasting for the Improvement of Facial Wrinkles and Skin Quality
Run by Skin Tech Pharma Group S.L.U. · NCT07551609 · Data updated 2026-11-12
Aging adults with facial wrinkles from sun exposure will try a hyaluronic acid product to see if it reduces wrinkles and improves skin quality.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 207 (estimated) |
| Sponsor | Skin Tech Pharma Group S.L.U. Industry-sponsored |
| Locations | 6 sites (Barcelona, Barcelona and 5 other locations) |
| Status | Recruiting |
| Started | April 26, 2026 |
| Main results expected | March 30, 2027 |
| Study ends | March 30, 2028 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07551609 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with moderate to severe facial wrinkles (SASSQ grade 2–3) and mild to moderate photoaging who consent to follow-up and forgo other facial procedures during the study.
✕Probably not a fit
Individuals without significant wrinkle or photodamage improvements, or who do not respond to the treatment, may not experience noticeable benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study tests the clinical performance and long-term safety of CE-marked RRS HA Long Lasting for treating photoaged facial skin. Participants with moderate to severe wrinkles and mild to moderate photodamage receive the product, with a comparison to an untreated control group to gauge effectiveness at 2 months. Outcomes focus on the proportion of responders with clinically meaningful wrinkle improvement and the degree of photodamage change. The study is conducted at three clinics in Barcelona, Spain. Enrolled adults provide informed consent and comply with follow-up visits to assess safety and efficacy.
Why it matters
Potential benefit: If successful, participants may experience noticeable reduction in facial wrinkles and improved skin quality.
How similar studies have gone: Previous work on HA fillers for photoaged skin has shown benefits in wrinkle reduction and skin quality, supporting this approach as plausible though specifics depend on formulation and protocol.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject has presence of grade 2 (moderate) or grade 3 (severe) wrinkles according to SASSQ. The Investigator evaluates the wrinkles on both sides of the face as grade 2 or 3 SASSQ; * Subject has mild to moderate photoaging according to Alexiades-Armenakas scale; * Subject is willing and able to provide informed consent and attend follow-up visits; * Subject is psychologically able to understand the study related information and to give a written informed consent (ICF); * Subject has voluntarily provided written informed consent to participate in the study, and use of data privacy (sign the EC approved ICF), prior to any study-related procedure being performed; * Subject is aged \>18 years; * Subject is seeking correction of his/her facial wrinkles, agrees with recommendation by the Investigator, and has a reasonable expectation of the treatment effect; * Subject accepts the obligation not to receive any other facial procedures or treatments impacting facial wrinkles at any time during the study (before their study exit); * Subject is able to follow study instructions and likely to complete all required visits, as assessed by the Investigator, agree to maintain existing skincare habits during the trial period; * Female of childbearing potential (who are sexually active, who do not have primary ovarian insufficiency, have not undergone hysterectomy or bilateral tubal ligation, who are not postmenopausal for at least 1 year) must have a negative urine pregnancy test (UPT) at screening (or prior to treatment on Visit 1) and Visit 3 (in case of touch-up treatment) and use a medically accepted contraceptive regimen (self-reported) since at least 12 weeks before the beginning of the study and during the study. Exclusion Criteria: In terms of population: * Subject is a pregnant or breastfeeding woman, or planning a pregnancy during the study; * Subject has scars, moles, tattoo, or anything on the face which might interfere with the evaluation; * Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship; * Subject in a social or sanitary establishment; * Subject participating to another research on human beings or who is in an exclusion period of one month from a previous study; * Subject needs to long-term outdoor work or long-term exposure to sunlight after treatment; * Subjects who intend to initiate or continue any intentional weight-loss program (including diet, medication, or increased physical activity) during the study period; * Subject has an adequate understanding of skin care after the treatment sessions: avoiding sun exposure, extreme temperature (sauna, hammam, etc.) or any source of UV rays 24 hours after the product application. In terms of associated pathology: * Subject presenting any symptom which can be related to a medical condition that is likely to make the subject not being compliant with the study schedule, at the discretion of the Investigator; * Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results; * Subject with known history of or suffering from autoimmune disease and/or immune deficiency, active connective tissue disorder (e.g., arthritis rheumatoid, scleroderma, and systemic lupus erythematosus), cancer, or receiving immunomodulatory agents; * Subject suffering from active inflammatory and/or infectious cutaneous disorders in or near the studied zones (e.g. herpes, acne). Subject with recurrent herpes in the wrinkle area is not eligible even if asymptomatic at time of inclusion; * Subject with a history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats with cardiac localization; * Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders; * Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid or any of the other device components of the product or local anesthetic cream; * Subject with a tendency to develop keloids or hypertrophic scars, or clinically significant skin pigmentation alterations. Relating to previous or ongoing treatment: * Subject participated in another clinical study in the last 30 days; * Subject having received facial treatment with a laser, a dermabrasion, a surgery, a peeling, or other ablative procedure within the past 6 months prior to inclusion; * Subject having received injection with a resorbable filling product in the face within the past 24 months prior to inclusion; * Subject having received at any time injection with a slowly resorbable filling product (e.g. polylactic acid, calcium hydroxyapatite, combinations of HA and Hypromellose) or with a non-resorbable filling product (e.g. polyacrylamide or silicone); * Subject having received at any time a treatment with tensor threads in the face; * Subject currently undergoing or planning to undergo dental procedures that affect facial observation during the study (e.g., orthodontics, tooth extraction, dental implantation, etc.); * Subjects having received surgical rhinoplasty procedure at any time; * Subject under medications which may cause lipo-atrophy (e.g. Ozempic); * Subject using medication such as aspirin, NSAIDs (e.g. ibuprofen), antiplatelet agents, anticoagulants, vitamin C within one week prior to inclusion or being a chronic user of anticoagulant treatment; * Subject undergoing a topical treatment on the test area or a systemic treatment: * Antibiotics and antihistamines during the 2 weeks prior to study start; * Immunosuppressors and/or corticoids during the 3 months prior to study start; * Retinoids during the 6 months prior to study start.
Where it's running
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Clinic Bascoy
Barcelona, Barcelona, Spain Recruiting -
Gal·la Clinic
Barcelona, Catalonia, Spain Recruiting -
Centre Mèdic de Cabo Bové
Barcelona, Catalonia, Spain Recruiting -
Aruma Clinic
Madrid, Madrid, Spain Recruiting -
Zurko Research, S.L.
Madrid, Madrid, Spain Recruiting -
Ocean Clinic
Marbella, Málaga, Spain Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.