Endocare Repair Efficacy Skincare Products in the Use of Post-laser Treatment

A Single-center, Prospective, Randomized, Double-blind, Self-controlled Clinical Study Evaluating the Efficacy and Safety of Endocare Repairing Skincare Product in Skin Recovery After Ablative Fractional Laser Treatment .

To Evaluate the Efficacy and Safety of Endocare Repair Efficacy Skincare Products in the Repair of Facial Skin Following Ablative Fractional Laser Treatment.

Study Overview

• Status: Completed
• Conditions: Laser Treatment
• Intervention / Treatment: Combination product: Active product contained 40% secretion of SCA; Combination product: Identical-appearing placebo cream

Detailed Description

A single-center, prospective, randomized, double-blind, split-face (hemifacial) self-controlled clinical trial was conducted with 24 participants aged 21-37 years who underwent fractional CO2 laser treatment on both sides of the face. A skincare product containing SCA was applied to one side, and a placebo moisturizer was applied to the other side. Evaluations were conducted immediately after treatment and on days 1, 3, 5, 7, 14, and 28 post-treatment. The primary outcome was the evaluation of microcolumn density under dermoscopy. Secondary outcomes included transepidermal water loss (TEWL), melanin index (MI), erythema index (EI), investigator global assessment (IGA), patient global assessment(PGA), and visual analog scale (VAS) for pain. Safety was evaluated by monitoring adverse events.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Individuals aged 30-65 years;
2. Candidates for ablative fractional laser treatment on the face;
3. Agree to undergo photographic documentation before and after the ablative fractional laser procedure and during follow-up visits;
4. Refrain from using other similar products (except facial cleansers) after ablative fractional laser treatment;
5. Written informed consent obtained.

Exclusion Criteria:

1. known hypersensitivity to product ingredients;
2. active skin infections;
3. history of keloid formation;
4. immunosuppressive therapy and pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SCA Side; One half of the face received the active product contained 40% secretion of SCA	Combination product: Active product contained 40% secretion of SCA; One half of the face received the active product contained 40% secretion of SCA covering all lasered areas.
Placebo Comparator: Placebo Side; The other half received an identical-appearing placebo cream (a basic moisturizer containing no SCA ingredients	Combination product: Identical-appearing placebo cream; The other half received an identical-appearing placebo cream (a basic moisturizer containing no SCA ingredients, but otherwise matching the active product in appearance and texture), covering all lasered areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microcolumn Density Under Dermoscopy	The primary outcome was the rate of re-epithelialization, assessed by the density of visible microcolumns which was examined using the Medicam®1000 dermoscopy system. This measure was complemented by a clinical healing score (0-3 scale for each side, where 0 = fully healed skin, 1 = fine pinpoint scaling, 2 = visible micro-crusts, 3 = obvious unhealed areas) assigned by a blinded dermatologist.	Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal Water Loss (TEWL)		Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28
Melanin Index (MI)	MI can detect pigment changes, allowing assessment of any PIH or other dyschromia resulting from the laser or differential healing. Higher MI indicates a prolonged post-laser reaction.	Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28
Erythema Index (EI)	EI quantifies redness to track the resolution of laser-induced erythema. Higher EI indicates a prolonged post-laser reaction.	Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28.
Investigator Global Assessment (IGA)	Key symptoms including erythema, edema, crusting, exudation and crusting were graded (with a score from 0-3) by the investigator at each visits. Erythema: 0 - No redness; - Light red or pink; - Moderate redness; - Bright red Edema: 0 - No edema; - Mild edema; - Moderate edema; - Severe diffuse edema Exudation: 0 - No exudation; - Mild exudation; - Moderate exudation; - Diffuse exudation Crusting: 0 - No crusting; - Thin crust; - Moderately thick crust; - Thick crust adherent to skin	Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28
Patient Self-Assessments (PGA)	Patients rated tightness and burning in a scale of 0-3. 0=none, 1=mild, 2=moderate, 3=severe.	Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28.
Visual Analog Scale (VAS)	Assessed immediately after treatment and at follow-up visits using a 0-10 VAS score. 10 being the highest pain.	Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28.

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ablative Fractional Laser Treatment; Repair of Facial Skin; Endocare
• Other Study ID Numbers: 2022-554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because this single-center study does not have a formal data sharing infrastructure, and participants did not provide consent for public data sharing. Aggregated results may be reported in publications or upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No