A Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE FERULIC) for Skin Repair Post Fraxel Laser Treatment

NCT ID: NCT06026085

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-11-30

Brief Summary

A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and satisfaction of the Skinceuticals skin care product (CE) for skin repair following fraxel laser treatment and explore the medical value of fraxel laser therapy combined with Skinceuticals skin care product

Conditions

Photo-damaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CE FERULIC

fraxel laser therapy combined with Skinceuticals skin care product(CE FERULIC) and routine sun protection

Group Type: EXPERIMENTAL

Skinceuticals skin care product(CE)

Intervention Type: OTHER

Skinceuticals skin care product(CE FERULIC)+routine sun protection

fraxel laser therapy

Intervention Type: OTHER

Fraxel DUAL 1550/1927 Laser System

0.9% normal saline

fraxel laser therapy combined with 0.9% normal saline and routine sun protection

Group Type: PLACEBO_COMPARATOR

fraxel laser therapy

Intervention Type: OTHER

Fraxel DUAL 1550/1927 Laser System

0.9% normal saline

Intervention Type: OTHER

0.9% normal saline+routine sun protection

Interventions

Skinceuticals skin care product(CE)

Skinceuticals skin care product(CE FERULIC)+routine sun protection

Intervention Type: OTHER

fraxel laser therapy

Fraxel DUAL 1550/1927 Laser System

Intervention Type: OTHER

0.9% normal saline

0.9% normal saline+routine sun protection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Chinese subjects aged 18-65 years (inclusive);

2. Subjects with Fitzpatrick skin type II-IV;

3. Subjects with mild to moderate facial photoaging lesions, including melasma, acne scars, fine skin lines, enlarged pores, and dark photoaging problems

4. Subjects with consistent facial skin status on both sides and planned to receive fraxel laser treatment;

5. Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;

6. Subjects understand the nature of the study and sign the informed consent form (ICF)

Exclusion Criteria

1. Subjects with photosensitive skin or photosensitization-related diseases;

2. Subjects with a history of skin pigmentation, such as pigmentation caused by sex hormone factors (pregnancy, oral contraceptives);

3. Subjects with hypertrophic scar or scar constitution;

4. Subjects with autoimmune diseases, endocrine diseases or liver diseases that may lead to skin color changes;

5. Subjects who have received steroid/phototoxic drugs or laser treatment on the face within 3 months before enrollment;

6. Subjects with a history of sun exposure within 2 weeks prior to enrollment;

7. Subjects who are known to be contraindicated to fraxel laser therapy or CE (or allergic to other skin care components);

8. Subjects with known infection and inflammation in the intended treatment site;

9. Female subjects who are pregnant, lactating or plan to become pregnant;

10. Subjects who plan to use other drugs affecting skin color or intend to undergo other laser therapy and sunbathing during the treatment;

11. Subjects who are participating in other drug or medical device clinical trials;

12. Other subjects who are not suitable for this study as assessed by the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DeYi Aesthetic Medical Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SKCFRX002

Identifier Type: -

Identifier Source: org_study_id