A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement
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
1 other identifier
interventional
60
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2024
CompletedFirst Posted
Study publicly available on registry
May 7, 2024
CompletedStudy Start
First participant enrolled
June 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedMay 13, 2024
May 1, 2024
8 months
May 2, 2024
May 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
DMSB01
EXPERIMENTALmPEG-PLA
Rejuran®
ACTIVE COMPARATORPN
Interventions
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®).
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®).
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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).
- 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))
- 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.
- History of bleeding disorder in past or present
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Jongho Kim, M.D.,Ph.D.
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2024
First Posted
May 7, 2024
Study Start
June 10, 2024
Primary Completion
January 31, 2025
Study Completion
April 30, 2025
Last Updated
May 13, 2024
Record last verified: 2024-05