Clinical Trial to Assess the Efficacy and Safety of EASYDEW MD REGEN Cream Containing Neopop-S.

NCT ID: NCT05982509

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2023-07-27

Brief Summary

The purpose of this clinical study is to evaluate the effect on skin regeneration after applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, to patients who have undergone picosure picosure laser skin treatment as needed.

Detailed Description

This clinical study is a researcher-led randomized control group comparative clinical study that is conducted prospectively for one month after applying medical devices for clinical research.

The subjects are those who have undergone a picosure laser procedure for therapeutic purposes on the skin tissue of the face or body, and a screening test is conducted after the subject (and/or legal representative) agrees in writing to participate in the clinical study.

The screening test results are evaluated, and subjects who meet the selection criteria and do not meet the exclusion criteria are registered in clinical research.

Participating subjects are randomly assigned to the control group and the study group using a random number table at a 5:5 ratio.

• Control group: 10 people without treatment
• Study Group: 10 People Applying EasyDu Regen MD Cream Clinical study subjects are randomly assigned to control and study groups. In the case of the study group, the Easy Dew Regen MD cream provided through prescription is applied twice a day (morning and evening) to the skin of the area where the picosure laser treatment has been performed and absorbed well. The control group is the non-chalant group. However, general moisturizers that were used at home rather than medical devices for one month after the procedure can be used, and they are applied twice a day (morning and evening) to the skin of the area where the laser treatment has been performed and absorbed well.

One month of clinical research medical device application will be observed, and subjects will regularly visit the research institution to evaluate its validity and safety during screening visits (Visit1), treatment (Visit2), 2 weeks after treatment (Visit3), and 1 month after treatment (Visit3) You will receive it.

Conditions

Laser-Induced Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

No intervention

Control group: 10 people without treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

Study Group: 10 People Applying EasyDew Regen MD Cream

Group Type: EXPERIMENTAL

EasyDew Regen MD Cream

Intervention Type: DEVICE

For the study group, I received the prescription Easy Dew Regen MD Cream from Picosure Laser Apply an appropriate amount twice a day (morning and evening) to the skin of the area so that it can be absorbed well do. The control group is the non-chalant group. However, for one month after the procedure, it is not a medical device The normal moisturizer you use at home is available, and the area where you have undergone laser treatment Apply it twice a day (morning and evening) to the skin so that it can be absorbed well.

Interventions

EasyDew Regen MD Cream

For the study group, I received the prescription Easy Dew Regen MD Cream from Picosure Laser Apply an appropriate amount twice a day (morning and evening) to the skin of the area so that it can be absorbed well do. The control group is the non-chalant group. However, for one month after the procedure, it is not a medical device The normal moisturizer you use at home is available, and the area where you have undergone laser treatment Apply it twice a day (morning and evening) to the skin so that it can be absorbed well.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Those aged 19 to 65 who have undergone picosure laser treatment on facial and body skin tissues
• Decided to participate in this clinical study and signed a written informed consent the subject

Exclusion Criteria

• Subjects with uncontrolled diabetes
• Subjects with uncontrolled hypertension and cardiovascular disease
• Subjects with hemorrhagic diseases such as hemophilia
• Immunosuppressants, corticosteroids, cytotoxic agents, and anticoagulants can affect the results Subjects who are or are scheduled to receive medication for an extended period of time
• Acute or chronic skin disease causes stage progression or active bacteria in the application area Who has a virus infection
• When the researcher's judgment determines that participation in the study is inappropriate (e.g. keloid constitution)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eun-ji Kim

INDUSTRY

Sponsor Role: lead

Responsible Party

Eun-ji Kim

Clinical Trial Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jihye Lee

Role: STUDY_DIRECTOR

CGBio Inc.

Locations

Ajou University Hospital

Gyeonggi-do, , South Korea

Countries

South Korea

Other Identifiers

G2204

Identifier Type: -

Identifier Source: org_study_id