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Study on the Effect of Topical Application of Tetracaine Hydrochloride Gel on the Vulva in Relieving Pain Caused by Photodynamic Therapy for Vulvar Lesions

Study on the Pain Relief Effect of Topical Application of Tetracaine Hydrochloride Gel in Photodynamic Therapy for Vulvar Lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102917
Enrollment
Unknown
Registered
2025-05-21
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Vulvar intraepithelial neoplasia(VIN),Vulvar condyloma acuminata,Lichen sclerosus of the vulva

Interventions

The control group (local cooling group):None
The study group (the group with tetracaine gel externally applied to the vulva):None

Sponsors

The international peace maternity and child health hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Clinically diagnosed vulvar lesions: vulvar condyloma acuminata, vulvar intraepithelial neoplasia, vulvar lichen sclerosus, with indications for photodynamic therapy; 2.The age ranges from 18 to 70 years old; 3.The patient has completed at least one standardized vulvar photodynamic therapy session, truthfully provided pain feedback, and undergone subsequent follow-ups; 4.The medical records are complete, including detailed treatment records, pain assessment using the Visual Analogue Score (VAS score), and records of adverse reactions.

Exclusion criteria

Exclusion criteria: 1.Combined with severe systemic critical illnesses such as severe cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, malignant tumors, etc., which affect pain perception and drug metabolism; 2.Known to be allergic to tetracaine, allergic to excitation light sources such as red light, or with a history of allergic constitution; 3.Women during pregnancy and lactation period; 4.Suffering from mental illness or cognitive impairment and unable to cooperate with the pain assessment and the research process; 5.Patients with severe damage and infection at the site of vulvar lesions, which may interfere with the absorption of drugs, affect the cooling effect of the air cooler, and impact the accuracy of pain assessment.

Design outcomes

Primary

MeasureTime frame
Self-Rating Anxiety Scale,SAS;Dermatology Life Quality Index,DLQI;Visual Analogue Scale,VAS;

Secondary

MeasureTime frame
The incidence rate of adverse reactions, covering local adverse reactions (such as redness, swelling, itching, etc.) and systemic adverse reactions (such as dizziness, nausea, etc.); track the treatme;

Countries

China

Contacts

Public ContactLei Bao

The international peace maternity and child health hospital

baolei1983@163.com+86 13817315100

Outcome results

None listed

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