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Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation

NCT05822778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-04-21

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. The main questions it aims to answer are:

* The differences of Wrinkle Severity Rating Scale (WSRS) after the injection.
* The differences of Global Aesthetic Improvement Scale (GAIS) after the injection.
* The subjective satisfaction of treatment.
* Safety Indicators of which incidences on the day of the injection or after the injection.

Participants will be self-controlled and randomized for same period

* received both trial product and control product at the same time.
* re-visited on week 2, 4, 12, 24, 36, and 52 after injection.

Researchers will compare if the test product is non-inferiority to Q-Med Restylane.

Conditions

  • Dermal Filler

Interventions

DEVICE

Formaderm Dermal Filler Injection

Dermal filler injection to facial areas

DEVICE

"Q-MED" RESTYLANE

Dermal filler injection to facial areas

Sponsors & Collaborators

  • Maxigen Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-13
Primary Completion
2015-03-15
Completion
2015-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05822778 on ClinicalTrials.gov