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To Evaluate the Efficacy and Safety of Endocare Repair Efficacy Skincare Products in the Repair of Facial Skin Following Ablative Fractional Laser Treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCA Side | Active Comparator | One half of the face received the active product contained 40% secretion of SCA |
|
| Placebo Side | Placebo Comparator | The other half received an identical-appearing placebo cream (a basic moisturizer containing no SCA ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active product contained 40% secretion of SCA | Combination Product | One half of the face received the active product contained 40% secretion of SCA covering all lasered areas. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | China |
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.
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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.
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| Identical-appearing placebo cream | Combination Product | 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. |
|
| 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
Edema: 0 - No edema
Exudation: 0 - No exudation
Crusting: 0 - No crusting
| 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. |