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

Study Overview
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Brief Summary
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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

Official Title
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A Prospective, Single-Center, Single-Blind, Randomized Split-Face Controlled Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE FERULIC) for Skin Repair Post Fraxel Laser Treatment in Real World Clinical Practice

Conditions
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Photo-damaging

Intervention / Treatment
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* Other: Skinceuticals skin care product(CE)
* Other: fraxel laser therapy
* Other: 0.9% normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese subjects aged 18-65 years (inclusive); Subjects with Fitzpatrick skin type II-IV; Subjects with mild to moderate facial photoaging lesions, including melasma, acne scars, fine skin lines, enlarged pores, and dark photoaging problems Subjects with consistent facial skin status on both sides and planned to receive fraxel laser treatment; Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures; Subjects understand the nature of the study and sign the informed consent form (ICF) Exclusion Criteria: Subjects with photosensitive skin or photosensitization-related diseases; Subjects with a history of skin pigmentation, such as pigmentation caused by sex hormone factors (pregnancy, oral contraceptives); Subjects with hypertrophic scar or scar constitution; Subjects with autoimmune diseases, endocrine diseases or liver diseases that may lead to skin color changes; Subjects who have received steroid/phototoxic drugs or laser treatment on the face within 3 months before enrollment; Subjects with a history of sun exposure within 2 weeks prior to enrollment; Subjects who are known to be contraindicated to fraxel laser therapy or CE (or allergic to other skin care components); Subjects with known infection and inflammation in the intended treatment site; Female subjects who are pregnant, lactating or plan to become pregnant; Subjects who plan to use other drugs affecting skin color or intend to undergo other laser therapy and sunbathing during the treatment; Subjects who are participating in other drug or medical device clinical trials; Other subjects who are not suitable for this study as assessed by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CE FERULIC<br>fraxel laser therapy combined with Skinceuticals skin care product(CE FERULIC) and routine sun protection | Other: Skinceuticals skin care product(CE)<br>* Skinceuticals skin care product(CE FERULIC)+routine sun protection<br>Other: fraxel laser therapy<br>* Fraxel DUAL 1550/1927 Laser System<br>|
| Placebo Comparator: 0.9% normal saline<br>fraxel laser therapy combined with 0.9% normal saline and routine sun protection | Other: fraxel laser therapy<br>* Fraxel DUAL 1550/1927 Laser System<br>Other: 0.9% normal saline<br>* 0.9% normal saline+routine sun protection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in erythema score | Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema) | at day 7 post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in erythema score | Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema) | days 1, 3 post-procedure | 
| Change from baseline in edema score | Score 0 - no edema, score 1 - mild edema, score 2 - moderate edema, score 3 - severe edema | days 1, 3,7 post-procedure | 
| Change from baseline in Erythema Index (EI) | EI values were measured on both sides of their faces with a multifunctional skin tester MPA20 (Courage Khazaka, Germany) + Mexameter MX18 probe | days 1, 3,7 post-procedure | 
| Change from baseline in melanin index(MI) | MI values were measured on both sides of their faces with a multifunctional skin tester MPA20 (Courage Khazaka, Germany) + Mexameter MX18 probe | days 1, 3,7 post-procedure | 
| Change from baseline in stratum corneum water content |  | days 1, 3,7 post-procedure | 
| Change from baseline in transepidermal water loss |  | days 1, 3,7 post-procedure | 
| Change from baseline in sebum rate |  | days 1, 3,7 post-procedure | 
| Subjects overall satisfaction | Satisfaction ratings were classified as: very satisfied, satisfied, dissatisfied, very dissatisfied | days 1, 3,7 post-procedure | 
| Scab and desquamation | Record the start scab formation time, start scab removal time and complete scab removal time of subjects | days 1, 3,7 post-procedure |