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Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia

NCT01256424 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2016-05-16

Study results available
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Summary

An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

DRUG

HAL 5% with illumination

Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation

DRUG

HAL 1% with illumination

Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation

DRUG

HAL 0.2% with illumination

Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation

DRUG

Placebo ointment without illumination

Treatment with a singe dose of 2g placebo ointment, no photoactivation

Sponsors & Collaborators

  • Photocure

    lead INDUSTRY

Principal Investigators

  • Peter Hillemanns, MD, PhD · University Hospital Hannover

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • Germany
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01256424 on ClinicalTrials.gov