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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2025-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Crow's Feet Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Randomized, Subject and Evaluator blinded, Matched pairs, Pilot Study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DMSB01

mPEG-PLA

Group Type EXPERIMENTAL

DMSB01

Intervention Type DEVICE

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®

PN

Group Type ACTIVE_COMPARATOR

Rejuran®

Intervention Type DEVICE

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®).

Interventions

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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®).

Intervention Type 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®).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No