Laser Treatment
Conditions
Keywords
Ablative Fractional Laser Treatment, Repair of Facial Skin, Endocare
Brief summary
To Evaluate the Efficacy and Safety of Endocare Repair Efficacy Skincare Products in the Repair of Facial Skin Following Ablative Fractional Laser Treatment.
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.
Interventions
COMBINATION_PRODUCTActive product contained 40% secretion of SCA
One half of the face received the active product contained 40% secretion of SCA covering all lasered areas.
COMBINATION_PRODUCTIdentical-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.
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
24 participants 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microcolumn Density Under Dermoscopy | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | 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) | 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 1. \- Light red or pink 2. \- Moderate redness 3. \- Bright red Edema: 0 - No edema 1. \- Mild edema 2. \- Moderate edema 3. \- Severe diffuse edema Exudation: 0 - No exudation 1. \- Mild exudation 2. \- Moderate exudation 3. \- Diffuse exudation Crusting: 0 - No crusting 1. \- Thin crust 2. \- Moderately thick crust 3. \- Thick crust adherent to skin |
| Patient Self-Assessments (PGA) | 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) | 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. |
Countries
China
Outcome results
None listed