NCT06026085Not yet recruitingNot Applicable
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
DeYi Aesthetic Medical Clinic0 sites50 target enrollmentStarted: September 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- Change in erythema score
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in erythema score
Time Frame: at day 7 post-procedure
Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)
Secondary Outcomes
- Change from baseline in erythema score(days 1, 3 post-procedure)
- Change from baseline in edema score(days 1, 3,7 post-procedure)
- Scab and desquamation(days 1, 3,7 post-procedure)
- Change from baseline in Erythema Index (EI)(days 1, 3,7 post-procedure)
- Change from baseline in stratum corneum water content(days 1, 3,7 post-procedure)
- Subjects overall satisfaction(days 1, 3,7 post-procedure)
- Change from baseline in melanin index(MI)(days 1, 3,7 post-procedure)
- Change from baseline in sebum rate(days 1, 3,7 post-procedure)
- Change from baseline in transepidermal water loss(days 1, 3,7 post-procedure)
Investigators
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