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

DeYi Aesthetic Medical Clinic

Status: Not yet enrolling

Conditions: Photo-damaging

Treatments: Other: Skinceuticals skin care product(CE); Other: fraxel laser therapy; Other: 0.9% normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06026085

SKCFRX002

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

CE FERULIC

Experimental group

Description:

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

Treatment:

Other: fraxel laser therapy

Other: Skinceuticals skin care product(CE)

0.9% normal saline

Placebo Comparator group

Description:

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

Treatment:

Other: 0.9% normal saline

Other: fraxel laser therapy