Soluble Hyaluronic Acid Microneedle VS. Non-ablative Fractional Laser on Infraorbital Wrinkles.

Clinical Controlled Study and Safety Evaluation of the Therapeutic Effect of Soluble Hyaluronic Acid Microneedle and Non-ablative Fractional Laser on Infraorbital Wrinkles

This study is a prospective half-face controlled study, aiming to evaluate the therapeutic effects and adverse reactions of soluble hyaluronic acid microneedle and non-ablative fractional laser on infraorbital wrinkles and compare them.

Study Overview

• Status: Recruiting
• Conditions: Wrinkle
• Intervention / Treatment: Procedure: Soluble Hyaluronic Acid Microneedle; Procedure: Non-fractional laser

Detailed Description

This study is a prospective half-face controlled study, aiming to evaluate the therapeutic effects and adverse reactions of soluble hyaluronic acid microneedle and non-ablative fractional laser on infraorbital wrinkles and compare them. The therapy is as follows:

1. Sign the informed consent form, and then the researchers will include and exclude patients according to the standards;
2. The researcher will collect the medical history, evaluate the condition, and determine the treatment plan after grouping by the random table;
3. Basic information collection 1) Take VISIA images (3 pictures of the front and sides at 45 degrees and several pictures of the skin lesions), and number and record the feature counts and specific scores of bilateral orbital wrinkles; 2) Measure and record the water content of the patient's periorbital skin;
4. Half face controlled treatment:

1) Drug preparation Drug: soluble hyaluronic acid microneedles; Equipment: ResurFX; 2) Treatment methods and operating procedures Microneedle side: Apply soluble hyaluronic acid microneedle eye mask to the periorbital area after normal facial cleansing and skin care every night for 20 days . Press and hold for 3 minutes, and then remove it after 1 h. Every 2 days for the next 20 days, and every 3 days for the last 21 days. Follow-up time: every 20 days during the treatment period, and follow-up in the second, fourth, eighth and twelfth week after the treatment.

Non-fractional laser side: The patient received non-ablative fractional laser treatment once. Follow-up time: follow-up visits in the 2nd, 4th, 8th and 12th weeks after the treatment.

3) End point of treatment Microneedle side: The soluble hyaluronic acid microcrystalline eye mask was used for 61 days according to the prescribed protocol. After the treatment, the patient entered the follow-up.

Fractional laser side: After one treatment, the patient enters the follow-up.

5. Follow-up after treatment Follow-up time: 2 weeks, 4 weeks, 8 weeks, 12 weeks after the end of treatment; Follow-up content: According to the follow-up plan, it is recommended that patients actively come to the hospital for follow-up. The follow-up time starts from the first day after the end of the last treatment. Record the patient's name, gender, age, adverse reactions, etc. in detail, take VISIA photos; test and record the skin moisture content, and fill in the patient satisfaction survey in the 4th week after treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yutong Yang; Phone Number: 17717095517; Email: dryutong@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200043
      • Recruiting
      • Shanghai skin disease hospital
      • Contact: Yutong Yang; Phone Number: 17717095517; Email: dryutong@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18-65 years old, Skin Aging Atlas: Volume 2, Asian type infraorbital wrinkles assessment standard score 3 points and above;
2. After fully explaining the purpose and content of this clinical trial (including the subjects' compliance, etc.), on the basis of full understanding, voluntarily sign an informed consent to participate in the clinical trial.

Exclusion Criteria:

1. Those who are known to be allergic to test drugs or related drugs;
2. Pregnant or lactating women;
3. Received wrinkle treatment (laser, radio frequency, fruit acid, photon, hyaluronic acid filling, etc.) within 6 months before enrollment;
4. Those who have other diseases (infection, dermatitis, sunburn, scars, etc.) that may affect the evaluation of the efficacy of the facial treatment area and nearby areas;
5. Received anti-inflammatory, glucocorticoid or tretinoin treatment within 1 month before enrollment;
6. Participate in any drug clinical trial (as a subject) within 1 month before participating in this trial;
7. Combined with serious diseases, including severe heart disease,cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, etc.;
8. Those with scar constitution;
9. Subjects with severe physical or mental illness that the investigator believes may affect treatment, evaluation, or poor compliance with the research protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microneedle side; Apply soluble hyaluronic acid microneedle eye mask to the periorbital area after normal facial cleansing and skin care every night for 20 days. Press and hold for 3 minutes, and then remove it after 1 h. Every 2 days for the next 20 days, and every 3 days for the last 21 days. Follow-up time: every 20 days during the treatment period, and follow-up visits in the 2nd, 4th, 8th and 12th weeks after the treatment.	Procedure: Soluble Hyaluronic Acid Microneedle; The soluble hyaluronic acid microneedle eye mask is a nanometer-sized microneedle made of water-soluble hyaluronic acid, which can directly inject the active ingredients into the dermis, and after being absorbed and dissolved by the skin, it can achieve the purpose of improving the water content and elasticity of the skin.
Active Comparator: Non-fractional laser side; The patient received non-ablative fractional laser treatment once. Follow-up time: follow-up visits in the 2nd, 4th, 8th and 12th weeks after the treatment.	Procedure: Non-fractional laser; he non-ablative fractional laser use 1565nm fiber laser, which acts on the target base in the dermis-water. The beam penetrates the epidermis and acts on the dermis. Using the principle of focal light and heat, the tissue cells are heated to initiate the repair process, which promotes increased collagen synthesis, thereby Achieve the effect of firming the skin and improving wrinkles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective rate	The grade of infraorbital wrinkles is assessed by a visual scale. Effective rate is defined as the proportion of patients who get improvement of at least one grade.	4 weeks after the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reaction rate	The adverse reaction is recorded during the study, including erythema, edema, crust, inch and pain. Adverse reaction rate is defined as the proportion of patients who have these reactions respectively.	Within 12 weeks after the treatment

Collaborators and Investigators

• Sponsor: Shanghai Dermatology Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: microneedle; non-ablative fractional laser
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: ShanghaiDH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No