Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06914583

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

Led by IBSA Farmaceutici Italia Srl · Updated on 2025-04-06

500

Participants Needed

6

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years old at time of consent
  • Skin Fitzpatrick type II-IV
  • Seeking temporary improvement of dry facial skin and dull complexion
  • Suitable for injectable treatment as assessed by investigator
  • Agree not to use other medical cosmetic treatments during study
  • Voluntarily sign informed consent and able to comply with study requirements
Not Eligible

You will not qualify if you...

  • Allergy to hyaluronic acid or any product component
  • History of severe allergies or autoimmune disease
  • History of herpes cutis or cicatricial diathesis
  • Presence of unknown injection substances in facial area
  • Received permanent or semi-permanent facial fillers or face lift procedures, or plan to during study
  • Received temporary dermal filler treatment within 12 months, or plan to during study
  • Received botulinum toxin, mesotherapy, or facial cosmetic procedures within 6 months, or plan to during study
  • Received sodium hyaluronate injections (mesotherapy) in facial area within 3 months
  • Active or progressive facial skin infection or skin granuloma
  • Active or progressive facial skin diseases or isomorphic reactions
  • Malignant or unknown nature skin tumors on face
  • Work outdoors for long periods or require sun exposure after surgery
  • Excessive expectations of treatment effects
  • Coagulation dysfunction or systemic diseases
  • Undergoing chemotherapy or radiotherapy
  • Mental illness or emotional instability
  • Received thrombolytic, anticoagulant, or antiplatelet drugs within 2 weeks
  • Pregnant, planning pregnancy, or breastfeeding
  • Participated in other clinical trials within 1 month or currently participating
  • Investigator deems unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Peking Union Medical College Hospital (PUMCH)

Beijing, China

Actively Recruiting

2

Peking University First Hospital

Beijing, China

Actively Recruiting

3

The First Principle Hospital of Changde City

Changde, China

Actively Recruiting

4

West China Hospital of Stomatology Sichuan Hospital

Chengdu, China

Actively Recruiting

5

Tongji Hospital of Tongji University

Shanghai, China

Not Yet Recruiting

6

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, China

Not Yet Recruiting

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Research Team

Y

Yan Wu, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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