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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical observational study focuses on healthy Chinese female volunteers aged 18 to 60 with skin types III to V. It investigates how different intensities of fractional ablative (CO2) and non-ablative (M22) lasers affect skin damage and repair. The study aims to understand the relationship between laser energy levels and skin responses, providing a foundation for future cosmetic treatment research. Participants receive both types of lasers applied to their inner forearms, with four different energy and density settings per laser on separate small test areas. The ablative CO2 laser creates microscopic thermal injury columns, while the non-ablative 1565 nm laser delivers focused energy below the skin surface without disrupting the outer layer. Each participant acts as their own control with treatments on opposite arms. Throughout the study, skin responses are assessed at multiple time points: before treatment, immediately after, and up to 10 days post-exposure. Researchers use clinical evaluations such as swelling and redness, standardized photos, high-frequency ultrasound, and instruments measuring skin color, melanin, hemoglobin, and barrier function. The primary outcome is the change in a composite skin damage score, with additional measurements tracking color and barrier changes to understand acute injury and healing patterns.
CONDITIONS
Brief 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 (scars, ulcers, vesicles, tattoos) on test sites
- No participation in other studies involving test area in past 2 months
- Agree not to use skin-whitening products on test area during study
- In good general health at study time
- Volunteer and provide signed informed consent and photo release
- Willing to comply with all study requirements
You will not qualify if you...
- Skin diseases or allergies in test area
- Moderate to severe inflammatory skin diseases on test sites within past 4 weeks or requiring corticosteroid/immunosuppressant treatment
- Significant diffuse erythema, desquamation, or exudation affecting skin color measurement on visit day
- 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 incisions, or pigmented lesions on test area affecting assessment
- Frequent use (3+ times/week for 4+ weeks) in past 3 months of high-potency active skin products on test area
- Recent moderate to severe sun exposure causing tanning or sunburn in test area within past 4 weeks
- Participation in other skin condition studies involving test area within past 4 weeks
- Significant mental or cognitive impairment affecting study compliance or understanding of procedures and tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive ablative and non-ablative fractional laser treatments on test areas of the inner forearm to study skin response and healing.
1 treatment visit (in-person)
Duration - 10 days
Participants are monitored for changes in skin damage, color, melanin and hemoglobin levels, and transepidermal water loss following laser treatments.
Multiple assessments at baseline, immediately post-treatment, 30 minutes, 1, 2, 3, 4 hours, 7 days, and 10 days post-treatment
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here