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

Espad Pharmed

Status

Completed

Conditions

Skin Aging

Treatments

Device: Hyaluronic Acid (HA)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06844760

PERB.ESP.VL.IV.03

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

35 to 60 years old

Volunteers

No Healthy Volunteers

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