Clinical trial NCT05813483: A Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE) for Skin Repair Post Fraxel Laser Treatment
Official title: 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) for Skin Repair Post Fraxel Laser Treatment in Real World Clinical Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Photo-damaging
Lead sponsor: DeYi Aesthetic Medical Clinic
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in erythema score
timeFrame: at day 7 post-procedure
Secondary outcomes:
measure: Change from baseline in erythema score
timeFrame: days 1, 3, 5 post-procedure
measure: Change from baseline in edema score
timeFrame: days 1, 3, 5 ,7 post-procedure
measure: Change from baseline in Erythema Index (EI)
timeFrame: days 1, 3, 5 ,7 post-procedure
measure: Change from baseline in melanin index(MI) Change from baseline in melanin index(MI)
timeFrame: days 1, 3, 5 ,7 post-procedure
measure: Change from baseline in stratum corneum water content
timeFrame: days 1, 3, 5 ,7 post-procedure
measure: Change from baseline in transepidermal water loss
timeFrame: days 1, 3, 5 ,7 post-procedure
measure: Change from baseline in sebum rate
timeFrame: days 1, 3, 5 ,7 post-procedure
measure: Subjects overall satisfaction
timeFrame: days 1, 3, 5 ,7 post-procedure
Other outcomes:
Locations:
Study officials:
References: