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

NCT07551609 | Not Yet Recruiting

• 1 other identifier: STPG_MD_CLI_PMCF_25_01_RRSHALL
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Photoaged Facial Skin; Photoaging; Wrinkle Reduction; Skin Quality Improvement

Keywords

photoaging, hyaluronic acid, wrinkles, skin quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (3)

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

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.

Device: RRS® HA Long Lasting

Interventions

RRS® HA Long Lasting DEVICE

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

RRS® HA Long Lasting double treatment; RRS® HA Long Lasting single treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 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;

Sponsors & Collaborators

• Skin Tech Pharma Group S.L.U.: lead

Study Sites (1)

Ocean Clinic

Marbella, Málaga, 29601, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 27, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)