Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Neck Area

Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Rejuvenation, Hydration, and Elasticity Improvement of the Neck Area

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 Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Device: Hyaluronic Acid (HA)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Private Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 35 and 60 years (inclusive)
• The presence of visible signs of skin aging, mainly dry neck skin, rough neck skin, loss of elasticity and clear lines and wrinkles (grades 2, 3, and 4 based on the IBSA Neck Laxity Scale)
• Able to follow study instructions and likely to complete all required visits
• Signing the informed consent form and agreeing to the 6-month follow-up

Exclusion Criteria:

• Previous treatment with fillers containing hyaluronic acid in the neck area during the last year
• History of using RF, rejuvenating lasers or intense pulsed light in the last 6 months
• Having systemic diseases that affect skin health, such as vascular collagen diseases, diabetes, hypothyroidism, liver and kidney failure.
• History of systemic use of drugs affecting the skin such as glucocorticoids, isotretinoin, immunomodulators and hormonal drugs in the last 3 months
• History of taking supplements containing collagen, hyaluronic acid and vitamin C in the last 3 months
• History of using topical corticosteroids and retinoids in the last 4 weeks
• Using topical cosmetic products containing anti-aging ingredients in the last 2 weeks
• Pregnant and lactating women
• History of active smoking during the last 2 years
• Major change in lifestyle including diet and physical activities and sun exposure during the study
• History of previous allergy to hyaluronic acid or lidocaine
• Any inflammation, active infection, unhealed old wound, and skin lesions in the injection area
• Using any anticoagulant product, NSAID, or any other drug that increases the risk of coagulation disorders, in the last 7 days
• History of anaphylactic shock
• Being prone to hypertrophic scar formation
• History of autoimmune disease or immune deficiency or using immunosuppressant drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perleux body	Device: Hyaluronic Acid (HA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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
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
Safety assessment	Assessment of adverse events following treatment	Day 0 and weeks 4, 8, 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
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

Collaborators and Investigators

• Sponsor: Espad Pharmed

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2024
• Primary Completion (Actual): October 24, 2024
• Study Completion (Actual): October 24, 2024

Study Registration Dates

• First Submitted: February 8, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: PERB.ESP.VL.IV.03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No