Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSkin Tech Pharma Group S.L.U.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Sequential
Treatments tested in this trial
RRS® HA Long Lasting
DeviceRRS® HA Long Lasting is a sterile medical device, Class III, dermal implant that contains cross-linked, resorbable Hyaluronic acid (HA).
Treatment groups
207 Participants
are divided into 3 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: RRS® HA Long Lasting single treatmentExperimental treatment 1 intervention
Group C: RRS® HA Long Lasting double treatmentExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
2 monthsSecondary outcomes
1
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 months2
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-up3
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-up4
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-upSponsors and contacts
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Source ClinicalTrials.gov