- ICH GCP
- US Clinical Trials Registry
- 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
April 3, 2023 updated by: DeYi Aesthetic Medical Clinic
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
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test group
fraxel laser therapy combined with Skinceuticals skin care product(CE) and routine moisturizing and sun protection
|
fraxel laser therapy combined with Skinceuticals skin care product(CE) and routine moisturizing and sun protection
fraxel laser therapy combined with routine moisturizing and sun protection
|
Other: Control group
fraxel laser therapy combined with routine moisturizing and sun protection
|
fraxel laser therapy combined with routine moisturizing and sun protection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
at day 7 post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in erythema score
Time Frame: days 1, 3, 5 post-procedure
|
Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)
|
days 1, 3, 5 post-procedure
|
Change from baseline in edema score
Time Frame: days 1, 3, 5 ,7 post-procedure
|
Score 0 - no edema, score 1 - mild edema, score 2 - moderate edema, score 3 - severe edema
|
days 1, 3, 5 ,7 post-procedure
|
Change from baseline in Erythema Index (EI)
Time Frame: days 1, 3, 5 ,7 post-procedure
|
days 1, 3, 5 ,7 post-procedure
|
|
Change from baseline in melanin index(MI) Change from baseline in melanin index(MI)
Time Frame: days 1, 3, 5 ,7 post-procedure
|
days 1, 3, 5 ,7 post-procedure
|
|
Change from baseline in stratum corneum water content
Time Frame: days 1, 3, 5 ,7 post-procedure
|
days 1, 3, 5 ,7 post-procedure
|
|
Change from baseline in transepidermal water loss
Time Frame: days 1, 3, 5 ,7 post-procedure
|
days 1, 3, 5 ,7 post-procedure
|
|
Change from baseline in sebum rate
Time Frame: days 1, 3, 5 ,7 post-procedure
|
days 1, 3, 5 ,7 post-procedure
|
|
Subjects overall satisfaction
Time Frame: days 1, 3, 5 ,7 post-procedure
|
Satisfaction ratings were classified as: very satisfied, satisfied, dissatisfied, very dissatisfied
|
days 1, 3, 5 ,7 post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 17, 2023
Primary Completion (Anticipated)
September 30, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
April 3, 2023
First Submitted That Met QC Criteria
April 3, 2023
First Posted (Actual)
April 14, 2023
Study Record Updates
Last Update Posted (Actual)
April 14, 2023
Last Update Submitted That Met QC Criteria
April 3, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- SKCFRX001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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