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A prospective, randomized, half-face self-controlled clinical trial of a novel high-frequency dot-matrix microneedle technique for the treatment of dark circles

A prospective, randomized, half-face self-controlled clinical trial of a novel high-frequency dot-matrix microneedle technique for the treatment of dark circles

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118699
Enrollment
Unknown
Registered
2026-02-10
Start date
2026-02-15
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Mixed type black eye (pigment type)

Interventions

Patients with mixed dark circles under the eyes:A total of 30 healthy research participants who met the clinical diagnosis of mixed dark circles (mainly pigmentary type) were recruited for this study.

Sponsors

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

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Consistent with the diagnosis of mixed-type dark circles (pigment-based) in patients aged 20–50 years old (including 20 and 50 years old), both men and women; 2. Never received any other treatment in the previous 3 months; 3. Study participants agreed to avoid any facial dermatology surgery or treatment other than the study intervention during the treatment and observation period; 4. Patients with no significant asymmetry between left and right facial dark circles; 5. After full understanding of treatment options and risks, the participant or guardian voluntarily signed the informed consent form and agreed to comply with follow-up.

Exclusion criteria

Exclusion criteria: 1. History of active skin disease, skin malignancy, immunosuppression, poor wound healing or keloid formation, local anesthetics and alcohol allergy in the presence of facial infection; 2. Women during lactation or pregnancy; 3. Those with severe heart, brain, lung, liver, and kidney function impairment, a history of mental or psychological disorders, or recent alcoholism or drug abuse; 4. Study participants unwilling to sign the informed consent form, or unwilling to cooperate with medical staff; 5. Patients participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
GAIS Score;

Secondary

MeasureTime frame
Facial Volume Change and Lift;Pre - and post-VISIA imaging images (spots, wrinkles, textures, pores, ultraviolet pigmentation spots, brown spots, red areas, purple matter and other indicators);Melanin Index Change;Patient Satisfaction Evaluation;

Countries

China

Contacts

Public ContactMa Gang

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

docmagang@126.com+86 21 23271699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026