Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Apr;24(4):e70117.
doi: 10.1111/jocd.70117.

Safety and Efficacy of a "High and Low Molecular Weight Hyaluronic Acid Hybrid Complex" Injection for Face Rejuvenation

Taraneh Yazdanparast  1 , Azin Ayatollahi  1 , Aniseh Samadi  1 , Araz Sabzvari  2 , Hamidreza Kafi  2 , Alireza Firooz  1
Affiliations
Clinical Trial

Safety and Efficacy of a "High and Low Molecular Weight Hyaluronic Acid Hybrid Complex" Injection for Face Rejuvenation

Taraneh Yazdanparast et al. J Cosmet Dermatol. 2025 Apr.

Abstract

Introduction: Hyaluronic acid (HA)-based formulations could have remarkable efficacy in treating a wide range of skin defects, including skin aging. The purpose of the study was the evaluation of the clinical safety and efficacy of a high and low molecular weight HA hybrid complex injection for skin rejuvenation.

Method: In this single-arm, before-and-after clinical study, 20 subjects with wrinkled, dry, or rough skin were enrolled. They received two treatment sessions, each of 2 mL of stabilized high- and low-molecular-weight HA through intradermal injections in five bioaesthetic points with an interval of 4 weeks. Efficacy assessment measures included biophysical and sonographic parameters and the Global Aesthetic Improvement Scale (GAIS) score. Pain assessment, safety profile, and subject satisfaction were also reported.

Results: A significant improvement in skin firmness was demonstrated in both follow-up visits. The Transepidermal water loss (TEWL) and the dermis ecodensity improved significantly in the first follow-up visit. A statistically significant increase in the dermis thickness was seen in the second follow-up visit. The median GAIS score indicated an average improvement of 51%-75%. The median overall satisfaction score was 7 and 6 in the first and second follow-up visits. No important side effects were observed. The average pain VAS score was 2 out of 10.

Conclusion: This new HA-based formulation is a safe and efficient treatment option to restore the vitality and turgidity of the skin.

Trial registration: ClinicalTrials.gov identifier: IRCT20150101020514N17 with ethics code IR.TUMS.TIPS.REC.1401.083.

Keywords: TEWL; dermis density; dermis thickness; elasticity; high and low molecular weight; hyaluronic acid; hydration.

PubMed Disclaimer

Conflict of interest statement

Araz Sabzvari is a member of CinnaGen medical biotechnology research center, which collaborates with universities and researchers all over the world with regards to research and development of medications and health issues. Hamidreza Kafi is the head of the medical department of Orchid Pharmed Company which is in collaboration with Espad Pharmed Daru Company with respect to conducting clinical trials. Other authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Representative schematic figure of injection points of the face (zygomatic protrusion, nasal base, tragus, chin, and mandibular angle).
FIGURE 2
FIGURE 2
Dermis thickness (unit: μm) and density (unit: Arbitrary) improvement in a 44‐year‐old man, evaluated by 22 MHz ultrasound probe (A: Before treatment/B: Week 12 after second treatment).
FIGURE 3
FIGURE 3
Participants' satisfaction based on the assessment of the skin conditions improvement. (Week 8 is first, and Week 16 is second follow‐up visit.)
FIGURE 4
FIGURE 4
Representative images of a 56‐year‐old woman. (A: Before/B: Week 4 after second treatment/C: Week 12 after second treatment.)
See this image and copyright information in PMC

References

    1. Akinbiyi T., Othman S., Familusi O., Calvert C., Card E. B., and Percec I., “Better Results in Facial Rejuvenation With Fillers,” Plastic and Reconstructive Surgery. Global Open 8, no. 10 (2020): e2763, 10.1097/GOX.0000000000002763. - DOI - PMC - PubMed
    1. Dayan S., Rivkin A., Sykes J. M., et al., “Aesthetic Treatment Positively Impacts Social Perception: Analysis of Subjects From the HARMONY Study,” Aesthetic Surgery Journal 39 (2019): 1380–1389. - PubMed
    1. Swift A., Liew S., Weinkle S., Garcia J. K., and Silberberg M. B., “The Facial Aging Process From the “Inside out”,” Aesthetic Surgery Journal 41 (2021): 1107–1119. - PMC - PubMed
    1. Humphrey S., Brown S. M., Cross S. J., and Mehta R., “Defining Skin Quality: Clinical Relevance, Terminology, and Assessment,” Dermatologic Surgery 47 (2021): 974. - PMC - PubMed
    1. Voegeli R., Campiche R., Biassin R., Rawlings A. V., Shackelford T. K., and Fink B., “Predictors of Female Age, Health, and Attractiveness Perception From Skin Feature Analysis of Digital Portraits in Five Ethnic Groups,” International Journal of Cosmetic Science 45 (2023): 672–687. - PubMed

Publication types

MeSH terms