New filler aims to smooth wrinkles and revive Sun-Damaged skin
NCT ID NCT07551609
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 3 times
Summary
This study tests a long-lasting hyaluronic acid filler (RRS® HA Long Lasting) to see if it safely improves facial wrinkles and skin quality in adults with sun-damaged skin. About 207 healthy adults with moderate to severe wrinkles will receive the filler on one side of the face, while the other side gets no treatment for comparison. The main goal is to check if the treated side shows a meaningful wrinkle improvement after two months.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 207 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Aruma Clinic
RECRUITINGMadrid, Madrid, 28001, Spain
Contact Email: •••••@•••••
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Centre Mèdic de Cabo Bové
RECRUITINGBarcelona, Catalonia, 08760, Spain
Contact Email: •••••@•••••
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Clinic Bascoy
RECRUITINGBarcelona, Barcelona, 08022, Spain
Contact Email: •••••@•••••
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Gal·la Clinic
RECRUITINGBarcelona, Catalonia, 08025, Spain
Contact Email: •••••@•••••
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Ocean Clinic
RECRUITINGMarbella, Málaga, 29601, Spain
Contact Email: •••••@•••••
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Zurko Research, S.L.
RECRUITINGMadrid, Madrid, 28023, Spain
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