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
Qualifiers
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
Treatments tested in this trial
- RRS® HA Long Lasting
Treatment groups
207 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov