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

DeYi Aesthetic Medical Clinic0 sites50 target enrollmentApril 17, 2023

ConditionsPhoto-damaging

Overview

Phase: N/A
Intervention: Not specified
Conditions: Photo-damaging
Sponsor: DeYi Aesthetic Medical Clinic
Enrollment: 50
Primary Endpoint: Change in erythema score
Status: Not Yet Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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

Registry

clinicaltrials.gov

Start Date

April 17, 2023

End Date

December 31, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

DeYi Aesthetic Medical Clinic

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Chinese subjects aged 18-65 years (inclusive);
•Subjects with Fitzpatrick skin type II-IV;
•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;

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, 5 post-procedure)
Change from baseline in edema score(days 1, 3, 5 ,7 post-procedure)
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)