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

May 10, 2024 updated by: Samyang Biopharmaceuticals Corporation

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DMSB01
mPEG-PLA
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®).
Active Comparator: Rejuran®
PN
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®).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
4, 8, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samyang Biopharmaceuticals Corporation

Investigators

  • Principal Investigator: Jongho KIM, M.D.,Ph.D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DMSB01_CF_301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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