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

Crow's Feet Lines Clinical Trial

Official title:

A Randomized, Subject and Evaluator Blinded, Matched Pairs, Pilot Study to Evaluate the Safety and Efficacy of DMSB01 According to the Number of Injections in Subjects With Crow's Feet Lines Compared to Control Device

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06402058
• Other study ID #: DMSB01_CF_301
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Samyang Biopharmaceuticals Corporation
• Contact: Gyeongsoon Kim
• Phone: +82-2-2157-9851
• Email: gyeongsoon.kim[@]samyang.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crow's Feet Lines

Intervention

Device:
• DMSB01
Apply a maximum of 1.0 ml for each side of the Crow's Feet Lines using both the test device (DMSB01) and the control device (Rejuran®).
• Rejuran®
Apply a maximum of 1.0 ml for each side of the Crow's Feet Lines using both the test device (DMSB01) and the control device (Rejuran®).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4, 8, 12 weeks