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

Eun-ji Kim

Status

Completed

Conditions

Laser-Induced Scar

Treatments

Device: EasyDew Regen MD Cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT05982509

G2204

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

19 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)