NCT07551609招募中不适用
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
Skin Tech Pharma Group S.L.U.6 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2026年4月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 207
- 试验地点
- 6
- 主要终点
- Wrinkle Severity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The primary efficacy endpoint is the percentage of responders, defined by at least 1 point improvement from baseline in facial wrinkles on both sides as measured by the blind evaluator at 2 months post last treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
No Intervention
Subjects will be randomized (2:1 ratio) to the RRS® HA Long Lasting (treatment) arm or the no-treatment control arm
RRS® HA Long Lasting single treatment
Experimental
Treatment Group Group 1: Single injection on Day 0
干预措施: RRS® HA Long Lasting (Device)
RRS® HA Long Lasting double treatment
Experimental
Treatment Group Group 2: Injection on Day 0 and a second (touch-up) injection on Day 30 if improvement is scored as <1 point on SASSQ wrinkle parameter by the PI and the subject.
干预措施: RRS® HA Long Lasting (Device)
结局指标
主要结局
Wrinkle Severity
时间窗: 2 months
The primary efficacy endpoint is the percentage of responders, defined by at least 1 point improvement from baseline in facial wrinkles as measured by the blind evaluator at 2 months post last treatment, assessed by the Scientific Assessment Scale of Skin Quality (SASSQ) wrinkle parameter, compared with no treatment control.
次要结局
- Wrinkle Severity(baseline, 1 month, 2, 3, and 6 months)
- Photodamage(baseline, 30 days (1 month), 2, 3, and 6 months of follow-up)
- Skin texture(baseline, 30 days (1 month), 2, 3, and 6 months of follow-up)
- Global Aesthetic Improvement(1 month, 2, 3, and 6 months of follow-up)
- Skin hydration(baseline, 1 month, 2, 3, and 6 months of follow-up)
- Subject & Investigator Satisfaction(6 months of follow-up)
- Product presence in tissue(before and immediately after injection, and at 6- and 12-months follow-up)
研究者
研究点 (6)
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