Status:
UNKNOWN
A Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE FERULIC) for Skin Repair Post Fraxel Laser Treatment
Lead Sponsor:
DeYi Aesthetic Medical Clinic
Conditions:
Photo-damaging
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06026085
Start Date
September 1 2023
End Date
November 30 2023
Last Update
September 6 2023
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