Photo-damagingNCT06026085
A Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE FERULIC) for Skin Repair Post Fraxel Laser Treatment
A study testing Skinceuticals skin care product(CE), fraxel laser therapy and 0.9% normal saline in people with Photo-damaging, run by DeYi Aesthetic Medical Clinic.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Photo-damaging
- What is being tested?
- Skinceuticals skin care product(CE), fraxel laser therapy and 0.9% normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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
About this study
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 FERULIC) 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
- Conditions
- Photo-damaging
- Being tested
- Skinceuticals skin care product(CE), fraxel laser therapy, 0.9% normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skinceuticals skin care product(CE)Other
Skinceuticals skin care product(CE FERULIC)+routine sun protection
fraxel laser therapyOther
Fraxel DUAL 1550/1927 Laser System
0.9% normal salineOther
0.9% normal saline+routine sun protection
| Study group | Role | What they receive |
|---|---|---|
| CE FERULIC | Experimental | fraxel laser therapy combined with Skinceuticals skin care product(CE FERULIC) and routine sun protection Receives: Other: Skinceuticals skin care product(CE); Other: fraxel laser therapy |
| 0.9% normal saline | Placebo comparator | fraxel laser therapy combined with 0.9% normal saline and routine sun protection Receives: Other: fraxel laser therapy; Other: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erythema score
Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)
Measured: at day 7 post-procedure
Secondary outcomes (9)
Change from baseline in erythema score
Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)
Measured: days 1, 3 post-procedure
Change from baseline in edema score
Score 0 - no edema, score 1 - mild edema, score 2 - moderate edema, score 3 - severe edema
Measured: days 1, 3,7 post-procedure
Change from baseline in Erythema Index (EI)
EI values were measured on both sides of their faces with a multifunctional skin tester MPA20 (Courage Khazaka, Germany) + Mexameter MX18 probe
Measured: days 1, 3,7 post-procedure
Change from baseline in melanin index(MI)
MI values were measured on both sides of their faces with a multifunctional skin tester MPA20 (Courage Khazaka, Germany) + Mexameter MX18 probe
Measured: days 1, 3,7 post-procedure
Change from baseline in stratum corneum water content
Measured: days 1, 3,7 post-procedure
Change from baseline in transepidermal water loss
Measured: days 1, 3,7 post-procedure
Change from baseline in sebum rate
Measured: days 1, 3,7 post-procedure
Subjects overall satisfaction
Satisfaction ratings were classified as: very satisfied, satisfied, dissatisfied, very dissatisfied
Measured: days 1, 3,7 post-procedure
Scab and desquamation
Record the start scab formation time, start scab removal time and complete scab removal time of subjects
Measured: days 1, 3,7 post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photo-damagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DeYi Aesthetic Medical Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026085
- Sponsor's protocol ID
- SKCFRX002
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 FERULIC) for Skin Repair Post Fraxel Laser Treatment in Real World Clinical Practice
- ClinicalTrials.gov ID
- NCT06026085
- Acronym / sponsor ID
- SKCFRX002
- Conditions
- Photo-damaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- DeYi Aesthetic Medical ClinicUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CE FERULIC | Experimental | Other: Skinceuticals skin care product(CE), Other: fraxel laser therapyfraxel laser therapy combined with Skinceuticals skin care product(CE FERULIC) and routine sun protection |
| 0.9% normal saline | Placebo comparator | Other: fraxel laser therapy, Other: 0.9% normal salinefraxel laser therapy combined with 0.9% normal saline and routine sun protection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skinceuticals skin care product(CE)Skinceuticals skin care product(CE FERULIC)+routine sun protection | Other | CE FERULIC |
| fraxel laser therapyFraxel DUAL 1550/1927 Laser System | Other | 0.9% normal saline, CE FERULIC |
| 0.9% normal saline0.9% normal saline+routine sun protection | Other | 0.9% normal saline |
Primary outcome
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)
9 secondary outcomes
Change from baseline in erythema score
Time frame: days 1, 3 post-procedure
Change from baseline in edema score
Time frame: days 1, 3,7 post-procedure
Change from baseline in Erythema Index (EI)
Time frame: days 1, 3,7 post-procedure
Change from baseline in melanin index(MI)
Time frame: days 1, 3,7 post-procedure
Change from baseline in stratum corneum water content
Time frame: days 1, 3,7 post-procedure
Change from baseline in transepidermal water loss
Time frame: days 1, 3,7 post-procedure
Change from baseline in sebum rate
Time frame: days 1, 3,7 post-procedure
Subjects overall satisfaction
Time frame: days 1, 3,7 post-procedure
Scab and desquamation
Time frame: days 1, 3,7 post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Skinceuticals skin care product(CE), fraxel laser therapy and 0.9% normal saline in people with Photo-damaging, run by DeYi Aesthetic Medical Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in erythema score (time frame: at day 7 post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.