This study aimed to evaluate the safety and effectiveness of stabilized Hyaluronic Acid Injection under the brand name Perleux body for neck skin rejuvenation, elasticity improvement, and hydration enhancement. Primary objective: Elasticity (R0, R2, and R5) improvement from baseline in neck area at weeks 8 and 16 Hypothesis: Perleux body (produced by Espad Pharmed Co.) has acceptable efficacy and safety profile for neck skin rejuvenation, elasticity improvement, and hydration enhancement. Secondary objectives: Effectiveness and safety assessment of Perleux body Study design: This is a phase IV, single-arm, and pre-post study Setting: Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.
Private Clinic
Tehran, Tehran Province, Iran
Skin elasticity measured with Cutometer
Change of elasticity parameters (R0, R2, and R5) at weeks 8 and 16 from the baseline visit
Time frame: weeks 8 and 16
Stratum corneum moisture
Change of stratum corneum moisture measured by MPA 580 probes in the neck area at weeks 8 and 16 from the baseline visit
Time frame: weeks 8 and 16
Transepidermal Water Loss (TEWL)
Change of TEWL measured by MPA 580 probes in the neck area at weeks 8 and 16 from the baseline visit
Time frame: weeks 8 and 16
General neck condition
Improvement in the clear lines and wrinkles of the neck area according to the Institut Biochimique SA (IBSA) Neck Laxity Scale, with grade 1 being normal tissue tone without noticeable laxity and grade 5 being severe laxity with extreme sagging, using before and after photos, by an independent physician
Time frame: weeks 8 and 16
Skin aging
Improvement in the clear lines and wrinkles of the neck area according to global aesthetic improvement scale (GAIS), with grade 1 being exceptional improvement and grade 5 being worsened, using before and after photos by an independent physician
Time frame: weeks 8 and 16
Pain intensity
Pain intensity using the VAS (visual analogue scale) \[from 0 (complete painlessness) to 10 (maximum pain imaginable)\].
Time frame: Day 0 and week 4
Participant satisfaction
Participant satisfaction by using the VAS \[from 0 (complete dissatisfaction) to 10 (complete satisfaction)\].
Time frame: weeks 8 and 16
Participant evaluation
Evaluation of participants on the improvement of their skin condition in terms of increased hydration, firmness and radiance, by a questionnaire designed by us. The questionnaire consists of five yes-or-no questions.
Time frame: weeks 8 and 16
Safety assessment
Assessment of adverse events following treatment
Time frame: Day 0 and weeks 4, 8, 16
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