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A multicentre controlled study of the efficacy and safety of photodynamic therapy for lower genital precancerous lesions

A multicentre controlled study of the efficacy and safety of photodynamic therapy for lower genital precancerous lesions

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046863
Enrollment
Unknown
Registered
2021-05-29
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Precancerous lesions of the lower reproductive tract

Interventions

Group Two:Photodynamics Therapy
Group One:Undergoing Leep operation
Group Three:Undergoing surgery
Group Four:Undergoing electric burning
Group Five:With drug treatment, 5-FU, VP-16, etc.

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: The patients were 20-65 years old and had a history of sexual life. 1. Vulvar intraepithelial lesions :VIN II, VIN III; 2. Patients with vaginal intraepithelial lesions: VaIN II, VaIN III; 3. Patients with cervical intraepithelial diseases: CIN II, CIN III; 4. The combination of 2-3 parts mentioned above.

Exclusion criteria

Exclusion criteria: 1. Patients with hemoporphyria; 2. Patients with confirmed malignant tumors of the lower reproductive tract; 3. The treatment area had received other treatment methods: cervical lesions had received cervical drugs (e.g., 5-FU, VP-16), physical, conical or total hysterectomy; vulva and vaginal lesions had received drug (e.g., 5-FU, VP-16), physical or surgical treatment 4. Pregnancy or lactation; 5. Active period of general infectious diseases; 6. Patients with hepatic failure; 7. Patients with severe mental disorder.

Design outcomes

Primary

MeasureTime frame
Cure rate;Response rate;

Secondary

MeasureTime frame
HPV eradication rate;

Countries

China

Contacts

Public ContactLi Ruizhen

Peking University Shenzhen Hospital

lrz6666@126.com+86 13924617095

Outcome results

None listed

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