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

Not Applicable

Not yet recruiting

• Conditions: Crow's Feet Lines
• Interventions: Device: DMSB01; Device: Rejuran®

• Registration Number: NCT06402058
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-07
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Study Start: 2024-06-10
• Primary Completion: 2025-01-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DMSB01	DMSB01	mPEG-PLA
Rejuran®	Rejuran®	PN

Primary Outcome Measures

Name	Time	Method
Changes in CFGS at 4, 8, 12 weeks after the last application of the clinical trial medical device compared to the baseline evaluated by Investigator and independent evaluators	4, 8, 12 weeks	The Crow's Feet Grading Scale is a 5-point scale with 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe and 4 = Extreme. 0 is the best outcome while 4 is the worst outcome. The higher scores mean a worse outcome.