Skip to content

Prospective, randomized, blind, non-inferiority, multicenter clinical trial protocol to evaluate the efficacy and safety of the

Prospective, randomized, blind, non-inferiority, multicenter clinical trial protocol to evaluate the efficacy and safety of the

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066400
Enrollment
Unknown
Registered
2022-12-05
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

wrinkle

Interventions

test group:Picosecond laser 1064 nm lattice handle
control group:M22 (ResurFX Laser treatment head)

Sponsors

Medical Ethics Committee of Dermatology Hospital (Institute), Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy adults aged 18-65 years (including 18 and 65 years), regardless of gender; 2) Fitzpatrick skin types II to V; 3) Mild to moderate periorbital wrinkles, Fitzpatrick wrinkle score of 3-6 (including 3 and 6); 4) Voluntarily receive treatment with laser therapy apparatus and cooperate with follow-up; 5) Sign informed consent voluntarily

Exclusion criteria

Exclusion criteria: 1) The subject refuses to sign the informed consent; 2) Sensitive to near infrared light; 3) People with a recent history of exposure to the sun; 4) Those who have taken drugs known to affect wound healing; 5) Patients with a history of photosensitive epilepsy; 6) Patients with a history of squamous cell carcinoma or melanoma; 7) Patients with a history of skin healing disorder or keloid, vitiligo or psoriasis; 8) Have a history of abnormal cotting function tests or cotting disorders, or are using anticoagulants; 9) Active local or systemic infection, or open wounds in the area to be treated; 10) Women who are pregnant or breastfeeding or who plan to become pregnant during the study period; 11) A medical condition, such as uncontrolled diabetes, that may interfere with the anesthesia, treatment or healing process; 12) Patients with herpes simplex attack (can be treated after preventive treatment); 13) Patients with melasma or post-inflammatory pigmentation in the treatment area; 14) Have received superficial chemical peels of hydroxy acid within 1 month; 15) Have received skin grinding treatment within 3 months; 16) Botox was injected into the treated area within six months; 17) Have participated or are participating in other clinical trials for drugs or medical devices within 3 months; 18) Any kind of open tear or abrasion, tattoo at the treatment site; 19) Subjects deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Facial Fitzpatrick Wrinkle Score;

Secondary

MeasureTime frame
VAS score;Subject Satisfaction;Product Performance Evaluation;

Countries

China

Contacts

Public ContactLin Tong

Hospital of Dermatology, Chinese Academy of Medical Sciences

ddlin@hotmail.com+86 13951902258

Outcome results

None listed

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