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A Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE FERULIC) for Skin Repair Post Fraxel Laser Treatment

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ClinicalTrials.gov Identifier: NCT06026085
Recruitment Status : Not yet recruiting
First Posted : September 6, 2023
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
DeYi Aesthetic Medical Clinic

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

Condition or disease Intervention/treatment Phase
Photo-damaging Other: Skinceuticals skin care product(CE) Other: fraxel laser therapy Other: 0.9% normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: 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 FERULIC) for Skin Repair Post Fraxel Laser Treatment in Real World Clinical Practice
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : November 30, 2023

Arm Intervention/treatment
Experimental: CE FERULIC
fraxel laser therapy combined with Skinceuticals skin care product(CE FERULIC) and routine sun protection
Other: Skinceuticals skin care product(CE)
Skinceuticals skin care product(CE FERULIC)+routine sun protection

Other: fraxel laser therapy
Fraxel DUAL 1550/1927 Laser System

Placebo Comparator: 0.9% normal saline
fraxel laser therapy combined with 0.9% normal saline and routine sun protection
Other: fraxel laser therapy
Fraxel DUAL 1550/1927 Laser System

Other: 0.9% normal saline
0.9% normal saline+routine sun protection




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline in erythema score [ Time Frame: days 1, 3 post-procedure ]
    Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)

  2. Change from baseline in edema score [ Time Frame: days 1, 3,7 post-procedure ]
    Score 0 - no edema, score 1 - mild edema, score 2 - moderate edema, score 3 - severe edema

  3. Change from baseline in Erythema Index (EI) [ Time Frame: days 1, 3,7 post-procedure ]
    EI values were measured on both sides of their faces with a multifunctional skin tester MPA20 (Courage Khazaka, Germany) + Mexameter MX18 probe

  4. Change from baseline in melanin index(MI) [ Time Frame: days 1, 3,7 post-procedure ]
    MI values were measured on both sides of their faces with a multifunctional skin tester MPA20 (Courage Khazaka, Germany) + Mexameter MX18 probe

  5. Change from baseline in stratum corneum water content [ Time Frame: days 1, 3,7 post-procedure ]
  6. Change from baseline in transepidermal water loss [ Time Frame: days 1, 3,7 post-procedure ]
  7. Change from baseline in sebum rate [ Time Frame: days 1, 3,7 post-procedure ]
  8. Subjects overall satisfaction [ Time Frame: days 1, 3,7 post-procedure ]
    Satisfaction ratings were classified as: very satisfied, satisfied, dissatisfied, very dissatisfied

  9. Scab and desquamation [ Time Frame: days 1, 3,7 post-procedure ]
    Record the start scab formation time, start scab removal time and complete scab removal time of subjects



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Chinese subjects aged 18-65 years (inclusive);
  2. Subjects with Fitzpatrick skin type II-IV;
  3. Subjects with mild to moderate facial photoaging lesions, including melasma, acne scars, fine skin lines, enlarged pores, and dark photoaging problems
  4. Subjects with consistent facial skin status on both sides and planned to receive fraxel laser treatment;
  5. Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
  6. 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
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Responsible Party: DeYi Aesthetic Medical Clinic
ClinicalTrials.gov Identifier: NCT06026085    
Other Study ID Numbers: SKCFRX002
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No