RecruitingNot ApplicableNCT07551609

Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality

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

Sponsor

Skin Tech Pharma Group S.L.U.

Enrollment

207 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

Skin Quality Improvement Photoaging Photoaged Facial Skin Wrinkle Reduction

Summary

The objective of this clinical study is to confirm the clinical performance and long-term safety of the CE-marked RRS® HA Long Lasting in the treatment of skin photoaging and its consequences, with a primary focus on improving facial wrinkles and skin quality in healthy adults. The main questions it aims to answer are: the proportion of responders achieving a clinically significant change in facial wrinkles from baseline to Month 2 on both sides of the face; improvement in photodamage compared to the control group at 2 months. Researchers will compare the group treated with RRS® HA Long Lasting to an untreated control group to evaluate the product's effectiveness in improving facial wrinkles and skin quality.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria32

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.