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Recruiting NCT07551609

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

Conditions: Photoaged Facial Skin, Photoaging, Wrinkle Reduction, Skin Quality Improvement

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 207
Sponsor: Skin Tech Pharma Group S.L.U.

Location: Clinic Bascoy Barcelona Barcelona

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 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07551609). StuddyBuddy aggregates publicly available trial information.