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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perleux body | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid (HA) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin elasticity measured with Cutometer | Change of elasticity parameters (R0, R2, and R5) at weeks 8 and 16 from the baseline visit | weeks 8 and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | weeks 8 and 16 |
| Transepidermal Water Loss (TEWL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Clinic | Tehran | Tehran Province | Iran |
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Change of TEWL measured by MPA 580 probes in the neck area at weeks 8 and 16 from the baseline visit
| 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 | 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 | weeks 8 and 16 |
| Pain intensity | Pain intensity using the VAS (visual analogue scale) [from 0 (complete painlessness) to 10 (maximum pain imaginable)]. | Day 0 and week 4 |
| Participant satisfaction | Participant satisfaction by using the VAS [from 0 (complete dissatisfaction) to 10 (complete satisfaction)]. | 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. | weeks 8 and 16 |
| Safety assessment | Assessment of adverse events following treatment | Day 0 and weeks 4, 8, 16 |