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The application of novel polymer microneedles combined with photoelectricity in skin pigmentation disorders

The application of novel polymer microneedles combined with photoelectricity in skin pigmentation disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116083
Enrollment
Unknown
Registered
2026-01-05
Start date
2026-01-10
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Vitiligo, pigmentation

Interventions

Hyperpigmentation:755nm picosecond laser, intense pulsed light, Q-switched laser
Vitiligo(a depigmentary skin disorder):308 nm excimer phototherapy, standard polymer microneedles, polymer microneedles with light-focusing functionality

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Vitiligo(a depigmentary skin disorder) Clinically diagnosed as non-segmental stable vitiligo by two or more dermatologists at the level of Deputy Director or above. Aged 18–65 years, gender not restricted. No concomitant dermatoses at study sites. No systemic use of immunosuppressants, glucocorticoids, or traditional Chinese medicine formulations within the preceding three months. No phototherapy or topical treatments within the last month. Participants agree not to enrol in other interventional studies during treatment. Willingness to undergo treatment, observation, and all examinations with good compliance; informed consent obtained prior to enrolment. 2.Hyperpigmented Skin Conditions Age 18–60 years, no gender restrictions; Manifestation as diffuse, uniform brown or dark brown lips, clinically assessed and diagnosed as benign lip pigmentation (physiological, post-inflammatory hyperpigmentation, etc.). Study participants must not have undergone any lip treatments within three months prior to enrolment. No concomitant acute facial dermatoses such as eczema, herpes, or warts. Willingness to undergo observation and examinations, good compliance, and signing of informed consent prior to enrolment. Study participants agree not to participate in other interventional studies during the treatment period.

Exclusion criteria

Exclusion criteria: 1.Vitiligo (a depigmentary skin disorder) Individuals with a tendency to develop keloids. Women of childbearing age who are pregnant, breastfeeding, or planning pregnancy in the near future. Patients with severe cardiac, hepatic, or renal dysfunction. Individuals with a history of psychiatric disorders or cognitive impairment. History of photosensitive disorders or cutaneous malignancies. Patients with concomitant severe medical conditions (e.g., cardiovascular disease, pulmonary infections) or immune disorders. Facial skin infections (e.g., herpes simplex, common warts) or localised trauma. Positive dermatographism or facial skin hypersensitivity. 2.Hyperpigmentation-related dermatoses Pregnant or breastfeeding women, smokers. Skin infections or photosensitivity, keloid-prone constitution, positive scratch test. Lip fillers, chemical peels, laser treatments, or similar procedures within three months prior to enrolment. Current systemic retinoid therapy, severe cheilitis, or active herpes labialis. Active lip lesions requiring biopsy to rule out malignancy; personal history of skin cancer or radiotherapy; immunodeficiency states. Secondary skin hyperpigmentation due to anaemia, jaundice, cyanosis, or thyroid dysfunction. Individuals engaged in outdoor work during the study period who cannot strictly adhere to sun protection measures. Patients with significant organ diseases (heart, liver, kidney) or malignant tumours. Any unstable condition or circumstance that may compromise patient safety or study compliance, such as intellectual disability or severe psychiatric disorders including schizophrenia.

Design outcomes

Primary

MeasureTime frame
Overall physician assessment, DLQI, VAS, patient self-assessment;VASI?VNS?DLQI?PhGVA?PaGIC-V;

Secondary

MeasureTime frame
Baseline Assessment;

Countries

China

Contacts

Public ContactRuixing Yu

China-Japan Friendship Hospital

yuruixing521@163.com+86 18511698131

Outcome results

None listed

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