Photoaged Facial SkinORACLE LLNCT07551609
Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality
A study testing RRS® HA Long Lasting in people with Photoaged Facial Skin and Photoaging, run by Skin Tech Pharma Group S.L.U. at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Photoaged Facial Skin, Photoaging, Wrinkle Reduction
- What is being tested?
- RRS® HA Long Lasting
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 6 sitesSpain
- Study dates
- 26 Apr 2026to 30 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Clinic Bascoy
Barcelona, Barcelona, 08022
Luciano Bascoy, Dr., +34699574611, clinic@bascoy.net
Luciano Bascoy, Dr.
- Recruiting
Gal·la Clinic
Barcelona, Catalonia, 08025
Maria del Pilar Di Salvo, Dr., +34624248070, info@gallaclinic.com
Maria del Pilar Di Salvo, Dr.
- Recruiting
Centre Mèdic de Cabo Bové
Barcelona, Catalonia, 08760
Isabel Bové Farré, Dr., +34937741506, info@decabobove.com
Isabel Bové Farré, Dr.
- Recruiting
Aruma Clinic
Madrid, Madrid, 28001
Andrea Marroquín Ramírez, Dr., +3465253835, info@arumaclinic.com
Andrea Marroquín Ramírez, Dr.
- Recruiting
Zurko Research, S.L.
Madrid, Madrid, 28023
Tamara Kueder, Dr., +34 660 061 429, tamara.kueder@zurkoresearch.com
Elena Martínez, +34 672 657 97, elena.martinez@zurkoresearch.com
- Recruiting
Ocean Clinic
Marbella, Málaga, 29601
Kai O. Kaye, Dr., +34 951 77 55, info@oceanclinic.net
Kai Kaye, Dr.
About this study
Official title: 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.
- Being tested
- RRS® HA Long Lasting
- Keywords
- photoaging, hyaluronic acid, wrinkles, skin quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRS® HA Long LastingDevice
RRS® HA Long Lasting is a sterile medical device, Class III, dermal implant that contains cross-linked, resorbable Hyaluronic acid (HA).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: RRS® HA Long Lasting |
| 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. Receives: Device: RRS® HA Long Lasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (7)
Wrinkle Severity
- A blinded live evaluator and the PI will assess the wrinkle severity by SASSQ
- Compared with baseline and no-treatment control
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month, 2, 3, and 6 months of follow-up
Skin hydration
- Site staff will assess skin hydration by Moisturemeter
- Compared with baseline
Measured: 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.
Measured: 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
Measured: before and immediately after injection, and at 6- and 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start26 Apr 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photoaged Facial SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Subjects will be randomized (2:1 ratio) to the RRS® HA Long Lasting (treatment) arm or the no-treatment control arm. Treatment Group includes Group 1: Single injection on Day 0 and 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skin Tech Pharma Group S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551609
- Sponsor's protocol ID
- STPG_MD_CLI_PMCF_25_01_RRSHALL
- Acronym
- ORACLE LL
- Status last verified
- Sep 2026
- First submitted
- 19 Apr 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No