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

Not Applicable

Not yet recruiting

• Conditions: Photo-damaging
• Interventions: Other: Skinceuticals skin care product(CE); Other: fraxel laser therapy

• Registration Number: NCT05813483
• Lead Sponsor: DeYi Aesthetic Medical Clinic

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-14
• Last Update Posted: 2023-04-14
• Study Start: 2023-04-17
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Chinese subjects aged 18-65 years (inclusive);
2. Subjects with Fitzpatrick skin type II-IV;
3. Subjects with consistent facial skin status on both sides and planned to receive fraxel laser treatment;
4. Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
5. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	fraxel laser therapy	fraxel laser therapy combined with Skinceuticals skin care product(CE) and routine moisturizing and sun protection
Test group	Skinceuticals skin care product(CE)	fraxel laser therapy combined with Skinceuticals skin care product(CE) and routine moisturizing and sun protection
Control group	fraxel laser therapy	fraxel laser therapy combined with routine moisturizing and sun protection

Primary Outcome Measures

Name	Time	Method
Change in erythema score	at day 7 post-procedure	Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in erythema score	days 1, 3, 5 post-procedure	Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)
Change from baseline in edema score	days 1, 3, 5 ,7 post-procedure	Score 0 - no edema, score 1 - mild edema, score 2 - moderate edema, score 3 - severe edema
Change from baseline in Erythema Index (EI)	days 1, 3, 5 ,7 post-procedure
Change from baseline in melanin index(MI) Change from baseline in melanin index(MI)	days 1, 3, 5 ,7 post-procedure
Change from baseline in stratum corneum water content	days 1, 3, 5 ,7 post-procedure
Change from baseline in transepidermal water loss	days 1, 3, 5 ,7 post-procedure
Change from baseline in sebum rate	days 1, 3, 5 ,7 post-procedure
Subjects overall satisfaction	days 1, 3, 5 ,7 post-procedure	Satisfaction ratings were classified as: very satisfied, satisfied, dissatisfied, very dissatisfied