Safety and Efficacy Evaluation of Sodium Hyaluronate 32mg/ml in Improving Facial Skin Dryness and Dullness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIBSA Farmaceutici Italia Srl
About this trial
The aim of the study is to evaluate the safety and efficacy of sodium hyaluronate 32 mg/ml in improving facial skin dryness and dullness. Subjects are randomized to the treatment group or to the control group. Only subjects in the treatment group are treated by intradermal injection.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years old and ≤65 years old (based on the time of signing the ICF), gender is not restricted;
Skin Fitzpatrick is classified as type II-IV;
Subjects who are seeking temporary improvement of their dry facial skin and dull complexion. The investigator has assessed the subjects are suitable for receiving injectable treatment to improve these conditions;
Subjects who have agreed not to use any other medical cosmetic treatments related to the study during the study period;
Disqualifiers
Known allergy to hyaluronic acid or any component of this product;
Known history of severe allergies;
Known history of severe autoimmune disease;
Subjects with episode of herpes cutis;
Trial design
Design model
Parallel
Treatments tested in this trial
Sodium Hyaluronate
DeviceSodium Hyaluronate 32 mg/ml
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator
Treatment effective rate (third-party blinded investigator assessment)
Time frame
12 weekSecondary outcomes
1
GAIS-Blinded evaluator
Treatment effective rate (third-party blinded investigator assessment)
Time frame
4week, 8week, 10week, 16week, 20week2
GAIS-Investigator
Treatment effective rate (treating investigator assessment)
Time frame
4week, 8week, 10week, 12week, 16week, 20week3
GAIS-Subject
Treatment effective rate (subject assessment)
Time frame
4week, 8week, 10week, 12week, 16week, 20week4
Improvement of skin moisture
Corneometer assessment
Time frame
4week, 8week, 10week, 12week, 16week, 20weekSponsors and contacts
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Source ClinicalTrials.gov