Huashan Hospital
Shanghai, Shanghai Municipality, 200040, China
Completed
NCT Number: NCT07442422
Endocare Repair Efficacy Skincare Products in the Use of Post-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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Individuals aged 30-65 years;
- Candidates for ablative fractional laser treatment on the face;
- Agree to undergo photographic documentation before and after the ablative fractional laser procedure and during follow-up visits;
- Refrain from using other similar products (except facial cleansers) after ablative fractional laser treatment;
- Written informed consent obtained.
Exclusion criteria
- known hypersensitivity to product ingredients;
- active skin infections;
- history of keloid formation;
- immunosuppressive therapy and pregnancy or lactation.
Treatment and study plan
Active product contained 40% secretion of SCA
Combination ProductOne half of the face received the active product contained 40% secretion of SCA covering all lasered areas.
Identical-appearing placebo cream
Combination ProductThe 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.
Primary outcomes
-
Microcolumn Density Under Dermoscopy
Time frame: Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28
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.
Secondary outcomes
-
Transepidermal Water Loss (TEWL)
Time frame: 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)
Time frame: Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28
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.
-
Erythema Index (EI)
Time frame: Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28.
EI quantifies redness to track the resolution of laser-induced erythema. Higher EI indicates a prolonged post-laser reaction.
-
Investigator Global Assessment (IGA)
Time frame: Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28
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
-
Patient Self-Assessments (PGA)
Time frame: Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28.
Patients rated tightness and burning in a scale of 0-3. 0=none, 1=mild, 2=moderate, 3=severe.
-
Visual Analog Scale (VAS)
Time frame: Day 0 (before laser, immediately after laser and after applying product) and on post-laser days 1, 3, 5, 7, 14, and 28.
Assessed immediately after treatment and at follow-up visits using a 0-10 VAS score. 10 being the highest pain.
Sponsors and collaborators
Lead sponsor
Huashan Hospital
Other
Registry information
Official study title
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 .
Important dates
- Study start
- 2023
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Mar 2, 2026
- Registry last updated
- Mar 2, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.