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

NCT04989361 | Unknown

• 1 other identifier: ShanghaiDH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wrinkle

Keywords

microneedle; non-ablative fractional laser

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse reaction rate

  Within 12 weeks after the treatment

Study Arms (2)

Microneedle side

EXPERIMENTAL

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

Non-fractional laser side

ACTIVE COMPARATOR

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

Interventions

Soluble Hyaluronic Acid Microneedle PROCEDURE

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.

Microneedle side

Non-fractional laser PROCEDURE

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.

Non-fractional laser side

Eligibility Criteria

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

You may qualify if:

• years old, Skin Aging Atlas: Volume 2, Asian type infraorbital wrinkles assessment standard score 3 points and above;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Dermatology Hospital: lead

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200043, China

RECRUITING

Central Study Contacts

Yutong Yang

CONTACT

17717095517; dryutong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professer

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: August 4, 2021
• Study Start: September 1, 2021
• Primary Completion: May 30, 2023
• Study Completion: July 1, 2023
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)