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

NCT06026085 | Unknown

• 1 other identifier: SKCFRX002
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Photo-damaging

Outcome Measures

Primary Outcomes (1)

• Change in erythema score

  Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)

  at day 7 post-procedure

Secondary Outcomes (9)

• Change from baseline in erythema score

  days 1, 3 post-procedure

• Change from baseline in edema score

  days 1, 3,7 post-procedure

• Change from baseline in Erythema Index (EI)

  days 1, 3,7 post-procedure

• Change from baseline in melanin index(MI)

  days 1, 3,7 post-procedure

• Change from baseline in stratum corneum water content

  days 1, 3,7 post-procedure

Study Arms (2)

CE FERULIC

EXPERIMENTAL

fraxel laser therapy combined with Skinceuticals skin care product(CE FERULIC) and routine sun protection

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

Other: fraxel laser therapy; Other: 0.9% normal saline

Interventions

Skinceuticals skin care product(CE) OTHER

Skinceuticals skin care product(CE FERULIC)+routine sun protection

CE FERULIC

fraxel laser therapy OTHER

Fraxel DUAL 1550/1927 Laser System

0.9% normal saline; CE FERULIC

0.9% normal saline OTHER

0.9% normal saline+routine sun protection

0.9% normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• DeYi Aesthetic Medical Clinic: lead

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-08