Safety and Efficacy Evaluation of Sodium Hyaluronate 32mg/ml in Improving Facial Skin Dryness and Dullness

NCT06914583 | Recruiting

• 1 other identifier: 23CHN-Pro-IT01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 6

Brief Summary

The aim of the study is to evaluate the safety and efficacy of sodium hyaluronate 32 mg/ml in improving facial skin dryness and dullness. Subjects are randomized to the treatment group or to the control group. Only subjects in the treatment group are treated by intradermal injection.

Conditions

Facial Dryness; Facial Dullness

Outcome Measures

Primary Outcomes (1)

• GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator

  Treatment effective rate (third-party blinded investigator assessment)

  12 week

Secondary Outcomes (39)

• GAIS-Blinded evaluator

  4week, 8week, 10week, 16week, 20week

• GAIS-Investigator

  4week, 8week, 10week, 12week, 16week, 20week

• GAIS-Subject

  4week, 8week, 10week, 12week, 16week, 20week

• Improvement of skin moisture

  4week, 8week, 10week, 12week, 16week, 20week

• Skin dryness improvement assessment - Investigator

  4week, 8week, 10week, 12week, 16week, 20week

Study Arms (2)

Treatment group

EXPERIMENTAL

The treatment group will receive intradermal injections of sodium hyaluronate

Device: Sodium Hyaluronate

Control group

NO INTERVENTION

The control group will not receive any treatment

Interventions

Sodium Hyaluronate DEVICE

Sodium Hyaluronate 32 mg/ml

Treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old and ≤65 years old (based on the time of signing the ICF), gender is not restricted;
• Skin Fitzpatrick is classified as type II-IV;
• Subjects who are seeking temporary improvement of their dry facial skin and dull complexion. The investigator has assessed the subjects are suitable for receiving injectable treatment to improve these conditions;
• Subjects who have agreed not to use any other medical cosmetic treatments related to the study during the study period;
• Subjects who voluntarily sign a written informed consent form, and able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on investigator's judgement.

You may not qualify if:

• Known allergy to hyaluronic acid or any component of this product;
• Known history of severe allergies;
• Known history of severe autoimmune disease;
• Subjects with episode of herpes cutis;
• Subjects with cicatricial diathesis;
• Facial area has unknown injection substances;
• Have received any permanent or semi-permanent fillers at the facial area (e.g., calcium hydroxyapatite, poly-L-lactic acid, polymethyl methacrylate, silicones, expanded polytetrafluoroethylene (ePTFE), polycaprolactone, etc.), autologous fat, face lift (including thread lifts), etc., or plan to receive any of the above treatments during the investigation;
• Have received temporary dermal filler treatment (e.g., cross-linked hyaluronic acid, collagen) at the facial area within the 12 months prior to enrolment, or plan to receive any of the above treatments during the investigation;
• Have received botulinum toxin injection, mesotherapy, or facial cosmetic procedures (e.g., facial liposuction, cosmetic surgery, face slimming, photo modulation therapy, intense pulsed light, radiofrequency, non-cross-linked hyaluronic acid injection (except for mesotherapy), dermabrasion, laser or chemical peels or other ablation procedures, etc.) at facial area within 6 months prior to enrolment, or plan to receive any of the above treatments during the investigation;
• Have received sodium hyaluronate compound solution injection (mesotherapy, etc) at facial area within 3 months prior to enrolment,
• Facial area has active or progressive skin infection (including viral, bacterial, fungal);
• Facial area has skin granuloma;
• Facial area has active or progressive skin diseases or with isomorphic reactions such as acute eczema, flat warts, lichen planus, psoriasis vulgaris, etc.;
• Facial area has malignant tumors or skin tumors of unknown nature;
• Subjects who work outdoors for a long time or need to be exposed to sunlight after surgery;

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead

Study Sites (6)

Peking Union Medical College Hospital (PUMCH)

Beijing, China

RECRUITING

Peking University First Hospital

Beijing, China

RECRUITING

The First Principle Hospital of Changde City

Changde, China

RECRUITING

West China Hospital of Stomatology Sichuan Hospital

Chengdu, China

RECRUITING

Tongji Hospital of Tongji University

Shanghai, China

NOT YET RECRUITING

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, China

NOT YET RECRUITING

Central Study Contacts

Yan Wu, Professor

CONTACT

13910978643; 3437477565@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 6, 2025
• Study Start: February 19, 2025
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Locations

CN (6)