35 kDa Hyaluronan Fragment (HA35) Reduces Chronic Inflammation of Skin

NCT ID: NCT06387212

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2024-05-31

Brief Summary

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To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems.

Detailed Description

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Conditions

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Skin Inflammation Cosmetic Skin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DermaShine PRO negative microneedles instrument

Group Type EXPERIMENTAL

35 kDa hyaluronan fragment HA35 injection

Intervention Type DRUG

First, apply an appropriate amount of compound lidocaine cream to the treatment site ( national drug approval number H20063466 ; Beijing Ziguang Pharmaceutical Co., Ltd. ) waited for 60 minutes after applying hemp, and then injected the syringe containing sterile HA35 prepared in advance into the subcutaneous 1.0-1.5mm through the DermaShine PRO negative pressure microneedle importer ( Demasha, South Korea ).

Interventions

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35 kDa hyaluronan fragment HA35 injection

First, apply an appropriate amount of compound lidocaine cream to the treatment site ( national drug approval number H20063466 ; Beijing Ziguang Pharmaceutical Co., Ltd. ) waited for 60 minutes after applying hemp, and then injected the syringe containing sterile HA35 prepared in advance into the subcutaneous 1.0-1.5mm through the DermaShine PRO negative pressure microneedle importer ( Demasha, South Korea ).

Intervention Type DRUG

Other Intervention Names

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HA35

Eligibility Criteria

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Inclusion Criteria

* Skin problems include but are not limited to dry skin, dark skin, and coarse pores.
* Chronic skin inflammation, pigmentation, erythema, etc.
* Cooperate with the experimental requirements and be able to complete the score independently。

Exclusion Criteria

* Pregnant or lactating women.
* Suffering from psychological or mental illness.
* Life is not regular, overeating.
* Hypersensitive to hyaluronic acid, and has a scar constitution.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nakhia Impex LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nahia Impex LLC

Ulaanbaatar, , Mongolia

Site Status RECRUITING

Countries

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Mongolia

Central Contacts

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Mizhou Hui

Role: CONTACT

13484005199

Facility Contacts

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Mizhou Hui

Role: primary

13484005199

Other Identifiers

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HUI0001

Identifier Type: -

Identifier Source: org_study_id

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