A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement

Samyang Biopharmaceuticals Corporation

Status: Not yet enrolling

Conditions: Crow's Feet Lines

Treatments: Device: Rejuran®; Device: DMSB01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06402058

DMSB01_CF_301

Details and patient eligibility

About

The objective of this Pilot Study is to verify the safety and efficacy of DMSB01 in the temporary improvement of Crow's Feet Lines

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Among those who desire improvement in both sides of the crow's feet and have a Crow's Feet Grading Scale (CFGS) score of 2 or higher for both relaxed and maximum smile conditions
2. Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study

Exclusion criteria

1. Individuals with abnormal findings in visual-related tests (visual acuity test, Confrontational visual fields test, ocular motility test), specifically those with low vision (best-corrected visual acuity of 0.3 or less in the better eye).
2. Individuals who need to take anticoagulants from 2 weeks before the application of the investigational medical device to 2 weeks after the final application (with the exception of low dosage aspirin 100mg (up to a maximum of 300mg/day))
3. Individuals who need to take Vitamin E preparations, NSAIDs, or collagen preparations from 1 week before the application of the investigational medical device to 1 week after the final application.
4. History of bleeding disorder in past or present

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

DMSB01

Experimental group

Description:

mPEG-PLA

Treatment:

Device: DMSB01

Rejuran®

Active Comparator group

Description:

PN

Treatment:

Device: Rejuran®