Actively Recruiting
Clinical Observational Study on Changes in Skin Physiological Parameters Following Ablative and Non-Ablative Fractional Laser Treatment at Different Doses
Led by ChinaNorm · Updated on 2026-05-01
20
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical observational study investigates the dose-response relationship between laser energy intensity and skin damage/repair by applying different parameter sets of fractional ablative (CO2) and non-ablative (M22) lasers to the inner forearms of approximately 20 healthy Chinese female volunteers (aged 18-60, Fitzpatrick skin types III-V) in a single-center, self-controlled design. Each participant receives both laser types on contralateral arms, with four distinct energy/density combinations per laser applied to separate test areas, and the dynamic skin responses are evaluated at baseline, immediately post-treatment, and at 30 minutes, 1, 2, 3, 4 hours, 7 days, and 10 days thereafter through clinical assessments (edema, erythema, etc.), standardized photography, high-frequency ultrasound (Dermascan), and objective instrumental measurements of skin color (Chromameter CM26dG), melanin/hemoglobin (Mexameter MX18), and barrier function (TEWL via Vapometer). The collected data will be analyzed using descriptive and comparative statistical methods to characterize the acute injury and recovery profiles, aiming to establish a foundational model for future post-procedure cosmetic intervention research.
CONDITIONS
Official Title
Clinical Observational Study on Changes in Skin Physiological Parameters Following Ablative and Non-Ablative Fractional Laser Treatment at Different Doses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female Chinese participants aged 18 to 60 years (inclusive)
- Fitzpatrick skin phototypes III, IV, or V
- Willing to receive both non-ablative fractional laser (M22) and ablative fractional laser (CO2) on test sites
- No primary or secondary lesions (such as scars, ulcers, vesicles, tattoos) on the test sites
- No participation in other studies involving the forearms in the past 2 months
- Agree not to use skin-whitening products on the test area during the study
- In good general health at the time of the study
- Voluntarily agree and sign informed consent and photo release
- Willing to comply with all study requirements
You will not qualify if you...
- Skin diseases or allergies on the test area
- Moderate to severe inflammatory skin diseases on test sites in past 4 weeks or requiring corticosteroid/immunosuppressant treatment
- Significant diffuse erythema, peeling, or exudation on test area on visit day that affects skin color measurement
- Currently suffering from stable or worsening disease
- Planning pregnancy, pregnant, or breastfeeding
- Immunodeficiency
- History of photosensitivity or photoallergy
- History of skin cancer or malignant melanoma
- Significant scars, tattoos, surgical cuts, or pigmented lesions on test area affecting assessments
- Frequent use (3+ times/week for 4+ weeks) of high-potency active skin products on test area in past 3 months
- Recent moderate to severe sun exposure causing tanning or sunburn on test area within 4 weeks
- Participation in other skin-related clinical or consumer studies within past 4 weeks
- Significant mental or cognitive impairment affecting ability to comply or understand study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, China, 200072
Actively Recruiting
Research Team
Y
Yanwen Jiang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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