Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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) 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yutong Yang | Contact | 17717095517 | dryutong@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Skin Disease Hospital | Recruiting | Shanghai | Shanghai Municipality | 200043 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|