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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
207
RRS® HA Long Lasting is a sterile medical device, Class III, dermal implant that contains cross-linked, resorbable Hyaluronic acid (HA).
Zurko Research, S.L.
Madrid, Madrid, Spain
RECRUITINGOcean Clinic
Marbella, Málaga, Spain
RECRUITINGWrinkle Severity
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.
Time frame: 2 months
Wrinkle Severity
* A blinded live evaluator and the PI will assess the wrinkle severity by SASSQ * Compared with baseline and no-treatment control
Time frame: baseline, 1 month, 2, 3, and 6 months
Photodamage
* A blinded live evaluator and the PI1 will assess the severity of photoaging. * Compared with baseline and no-treatment control
Time frame: baseline, 30 days (1 month), 2, 3, and 6 months of follow-up
Skin texture
* Site staff will assess skin texture by using photographs taken by imaging system * Compared with baseline and no-treatment control
Time frame: baseline, 30 days (1 month), 2, 3, and 6 months of follow-up
Global Aesthetic Improvement
* The treatment investigator and subject will assess overall facial skin quality improvement by Global Aesthetic Improvement Scale * Compared with baseline
Time frame: 1 month, 2, 3, and 6 months of follow-up
Skin hydration
* Site staff will assess skin hydration by Moisturemeter * Compared with baseline
Time frame: baseline, 1 month, 2, 3, and 6 months of follow-up
Subject & Investigator Satisfaction
Subjects and treatment investigators will answer the questionnaire to assess the satisfaction of investigational medical device performance after the treatment.
Time frame: 6 months of follow-up
Product presence in tissue
* The PI1 and/or a dermatologist with expertise in ultrasound imaging will assess product presence * Compared with baseline
Time frame: before and immediately after injection, and at 6- and 12-months follow-up
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