Effects of different CO2 and 1565 nm fractional laser doses on forearm skin healing

Clinical Observational Study on Changes in Skin Physiological Parameters Following Ablative and Non-Ablative Fractional Laser Treatment at Different Doses

This test looks at how different energy settings of CO2 and 1565 nm fractional lasers change skin damage and repair on the inner forearms of healthy Chinese women aged 18–60 with Fitzpatrick skin types III–V.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: ChinaNorm (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07561242 on ClinicalTrials.gov

What this trial studies

This is a single-center, self-controlled observational study in about 20 healthy Chinese female volunteers who receive both an ablative CO2 fractional laser and a non-ablative 1565 nm fractional laser on contralateral inner forearms. Each laser is applied to four separate test sites using different energy/density parameter sets to create a dose–response matrix. Skin responses are followed from baseline through immediate post-treatment and multiple early timepoints up to 10 days using clinical scoring (edema, erythema), standardized photography, high-frequency ultrasound, and objective instruments measuring color, melanin/hemoglobin, and barrier function (TEWL). The design focuses on dynamic, early wound and barrier changes after different laser intensities rather than therapeutic outcomes.

Who should consider this trial

Good fit: Ideal candidates are healthy Chinese women aged 18–60 with Fitzpatrick skin types III–V who have no lesions on the forearms and are willing to receive both CO2 and non-ablative fractional laser applications and attend follow-up visits.

Not a fit: People with active inflammatory skin disease at the test sites, those outside the specified age or skin-type ranges, or those seeking therapeutic treatment rather than observational data are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help clinicians choose laser settings that minimize unwanted skin damage and speed safe recovery after fractional laser procedures.

How similar studies have performed: Ablative and non-ablative fractional lasers have been well studied for skin effects, but direct within-subject dose-comparison with dense early timepoint barrier measurements is less commonly reported.

Eligibility criteria

Inclusion Criteria:

* Female Chinese study participants aged 18 to 60 years (inclusive).
* Fitzpatrick skin phototypes III, IV, or V.
* Willing to receive non-ablative fractional laser (M22) and ablative fractional laser (CO2) irradiation on the test sites during the study.
* No primary or secondary lesions (such as scars, ulcers, vesicles, tattoos) on the test sites.
* Has not participated in any other studies involving the test area (forearms) in the past 2 months.
* Agrees not to use skin-whitening products on the test area during the study period.
* In good general health at the time of the study.
* Volunteers to participate and signs the informed consent form and photo release authorization.
* Willing to comply with all requirements of the study.

Exclusion Criteria:

* Study participants with skin diseases or skin allergies in the test area.
* Presence of moderate to severe inflammatory skin diseases (e.g., active eczema, acute photosensitive dermatitis, etc.) on the test sites within the past 4 weeks, or those who require treatment with oral or topical corticosteroids or immunosuppressants for skin conditions.
* On the day of the visit, the investigator judges the presence of significant diffuse erythema, desquamation, or exudation in the test area that may significantly affect skin color measurement.
* The investigator assesses that the participant is currently suffering from a stable or progressively worsening disease.
* Participant is planning for pregnancy, is pregnant, or is breastfeeding (applicable to female participants only).
* Participant with immunodeficiency.
* Participant has a history of photosensitivity or photoallergy.
* Participant has a history of skin cancer or malignant melanoma.
* Presence of significant scars, tattoos, surgical incisions, or pigmented lesions (e.g., prominent birthmarks) in the test area that may affect assessment, and in the investigator's judgment, would impede normal imaging or scoring.
* Has used high-potency active products containing high concentrations of retinoic acid/retinol, alpha hydroxy acids, salicylic acid, etc., on the test area frequently (≥3 times per week) for an extended period (≥4 weeks) within the past 3 months, which, in the investigator's judgment, may significantly affect skin texture or barrier status.
* History of moderate to severe sun exposure (e.g., prolonged outdoor work, travel to seaside/high altitude) within the past 4 weeks, resulting in significant tanning or sunburn in the test area that, in the investigator's judgment, may interfere with study-related readings.
* Participation in other clinical or consumer testing projects involving the skin condition of the test area within the past 4 weeks.
* Presence of significant mental or cognitive impairment affecting compliance, and the investigator considers the participant unable to understand the study procedures or complete the tests as required.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai China-norm Quality Technical Service Co., Ltd. — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yanwen Jiang

Conditions Skin Barrier Function; Wound Healing