Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality (ORACLE LL)

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

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 Overview

• Status: Recruiting
• Conditions: Photoaging; Photoaged Facial Skin; Wrinkle Reduction; Skin Quality Improvement
• Intervention / Treatment: Device: RRS® HA Long Lasting

• Study Type: Interventional
• Enrollment (Estimated): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28023
      • Recruiting
      • Zurko Research, S.L.
      • Contact: Tamara Kueder, Dr.; Phone Number: +34 660 061 429; Email: tamara.kueder@zurkoresearch.com
      • Contact: Elena Martínez; Phone Number: +34 672 657 97; Email: elena.martinez@zurkoresearch.com
      • Principal Investigator: Tamara Kueder, Dr.
  • Málaga
    • Marbella, Málaga, Spain, 29601
      • Recruiting
      • Ocean Clinic
      • Contact: Kai O. Kaye, Dr.; Phone Number: +34 951 77 55; Email: info@oceanclinic.net
      • Principal Investigator: Kai Kaye, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Subjects will be randomized (2:1 ratio) to the RRS® HA Long Lasting (treatment) arm or the no-treatment control arm
Experimental: RRS® HA Long Lasting single treatment; Treatment Group Group 1: Single injection on Day 0	Device: 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).
Experimental: RRS® HA Long Lasting double treatment; 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.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle 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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Severity	A blinded live evaluator and the PI will assess the wrinkle severity by SASSQ; Compared with baseline and no-treatment control	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	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	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	1 month, 2, 3, and 6 months of follow-up
Skin hydration	Site staff will assess skin hydration by Moisturemeter; Compared with baseline	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.	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	before and immediately after injection, and at 6- and 12-months follow-up

Collaborators and Investigators

• Sponsor: Skin Tech Pharma Group S.L.U.

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: photoaging, hyaluronic acid, wrinkles, skin quality
• Other Study ID Numbers: STPG_MD_CLI_PMCF_25_01_RRSHALL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No