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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство RRS® HA Long Lasting
  RRS® HA Long Lasting is a sterile medical device, Class III, dermal implant that contains cross-linked, resorbable Hyaluronic acid (HA).

Первичные конечные точки

• Wrinkle Severity [Срок оценки: 2 months]

Вторичные конечные точки (7)

• Wrinkle Severity [Срок оценки: baseline, 1 month, 2, 3, and 6 months]
• Photodamage [Срок оценки: baseline, 30 days (1 month), 2, 3, and 6 months of follow-up]
• Skin texture [Срок оценки: baseline, 30 days (1 month), 2, 3, and 6 months of follow-up]
• Global Aesthetic Improvement [Срок оценки: 1 month, 2, 3, and 6 months of follow-up]
• Skin hydration [Срок оценки: baseline, 1 month, 2, 3, and 6 months of follow-up]
• Subject & Investigator Satisfaction [Срок оценки: 6 months of follow-up]
• Product presence in tissue [Срок оценки: before and immediately after injection, and at 6- and 12-months follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 5 центров

• Gal·la Clinic — Barcelona
• Centre Mèdic de Cabo Bové — Barcelona
• Aruma Clinic — Madrid
• Zurko Research, S.L. — Madrid
• Ocean Clinic — Marbella

Идентификаторы

NCT: NCT07551609 · STPG_MD_CLI_PMCF_25_01_RRSHALL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗