Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-03 @ 8:06 PM
Study NCT ID:
NCT04989361
Status:
UNKNOWN
Last Update Posted:
2022-06-15
First Post:
2021-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soluble Hyaluronic Acid Microneedle VS. Non-ablative Fractional Laser on Infraorbital Wrinkles.
Sponsor:
Shanghai Dermatology Hospital
Organization:
Study Overview
Official Title:
Clinical Controlled Study and Safety Evaluation of the Therapeutic Effect of Soluble Hyaluronic Acid Microneedle and Non-ablative Fractional Laser on Infraorbital Wrinkles
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: