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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Photo-damaging
• Intervention / Treatment: Other: Skinceuticals skin care product(CE); Other: fraxel laser therapy; Other: 0.9% normal saline

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: DeYi Aesthetic Medical Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Estimated): September 6, 2023

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SKCFRX002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No