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A randomized controlled study on the clinical efficacy of IPL and Fractional CO2 Laser in skin rejuvenation

A randomized controlled study on the clinical efficacy of IPL and Fractional CO2 Laser in skin rejuvenation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113900
Enrollment
Unknown
Registered
2025-12-04
Start date
2025-12-31
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin aging

Interventions

IPL Group:This study employs two types of phototherapy modalities. Among them, CO? fractional laser operates at a wavelength of 10600 nm, with settings including 5% coverage, energy density of 10~15 m
CO2 Group:IPL (intense pulsed light) therapy utilizes wavelengths of 560/590 nm, with parameters set to 2 pulses, energy density of 12~16 J/cm2, pulse interval of 30 ms, and pulse width of 4.0 ms~5.0

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1.Healthy Chinese woman; 2.Aged 35 or above and 64 or below; 3.The skin on both sides of the upper arms is moderately to severely loose. After assessment by a doctor, it is suitable to receive CO2 fractional laser and IPL treatment; 4.The skin has good tolerance, does not overreact to external stimuli, and is less likely to experience symptoms such as burning, flushing, stinging, and itching; 5.Skin type: Fitzpatrick ?; 6.The research participants were willing to receive both types of light therapy and could tolerate any possible discomfort during and after the treatment; 7.The research participants were willing to undergo skin biopsies on the inner side of their upper arms. And be able to accept that there might be slight scars left; 8.Be willing to read and sign the informed consent form; 9.Research participants who are willing to sign a statement allowing information collection and related information authorization; 10.Be willing to comply with all the requirements listed in the plan during the research period and report any discomfort; 11.There are no obvious scars, acne, pigmentation marks, tattoos or sparse hair in the upper arm test area, which will not affect the research results; 12.The study participants were willing to accept not taking a bath or swimming within 5 days after the first treatment. The sampling site must not come into contact with water within 5 to 7 days after each biopsy sample

Exclusion criteria

Exclusion criteria: 1.Research participants whom the lead researcher considered unsuitable for participation; 2.Pregnant or lactating women who changed, started or stopped taking oral contraceptives or any hormone therapy within 1.5 months prior to the start of the study; 3.Research participants with a history of active skin diseases, skin infections, as well as skin tumors, psoriasis, seborrheic dermatitis, and severe psoriasis; 4.Research participants with a tendency to form scars; 5.Currently taking or routinely taking systemic or topical corticosteroids, vasoconstrictors, antibiotics and anti-inflammatory drugs within two weeks before the start of the study; 6.Has a history of acute or chronic skin diseases, medical and/or physical illnesses (such as skin cancer, diabetes, asthma, hypertension, hyperthyroidism or hypothyroidism); 7.There is a history of drug and cosmetic allergies, especially lidocaine allergy; 8.Sensitive to local anesthetics; 9.Have a certain frequency (equal to or more than twice a week) of swimming, sauna or traditional physical medication (such as acupuncture, cupping, massage) habits; 10.Have received or are currently receiving any local or systemic treatment that may interfere with the expected effectiveness assessment of the study product within two weeks prior to the start of the study; 11.There are factors in life and work that may affect the healing of the upper arm skin (such as frequently lifting heavy objects, etc.); 12.Have received or planned to undergo medical aesthetic treatment within the last three months; 13.Within three months, I participated in the application research of other cosmetics on the upper arm skin; 14.Those who have a clear history of sun exposure, phototherapy, chemical peels within one month, or who cannot strictly protect themselves from the sun after treatment; 15.Suffering from blood disorders or taking medications that may affect platelet function (such as aspirin); 16.There is a history of hypertrophic scars and keloids during the skin healing process. And there are other factors that affect the observation of therapeutic effect; 17.Any employee of a cosmetics company, a testing company, or a hospital staff;

Design outcomes

Primary

MeasureTime frame
Structural morphology (H&E staining) and biology Biomarker immunohistochemistry;

Secondary

MeasureTime frame
Skin elasticity;Transdermal water loss (TEWL);The water content of the stratum corneum of the skin;Skin color (L*a*b*);Skin thickness/density;Proteomics;Upper arm treatment area image;

Countries

China

Contacts

Public ContactDong Jiying

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

5453809@qq.com+86 13917235344

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026