A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

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Cervical intraepithelial neoplasia
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Brief Title

A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

Official Title

Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study

Brief Summary

      The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of
      cervical precancerous lesions (dysplasia) in women that are referred for conisation
      (surgery).

Detailed Description

      Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of
      preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue
      preserving method that may become a good treatment option for these patients.

      This study will explore topical application of methyl aminolevulinate (MAL) and
      hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm).
      Different doses of MAL and HAL will be used with different application time, followed by
      illumination.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Lesion eradication

Secondary Outcome

 Eradication of lesion and HPV

Condition

Cervical Dysplasia

Intervention

methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

Study Arms / Comparison Groups

 MAL 3
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

96

Start Date

August 2006

Completion Date

July 2009

Primary Completion Date

July 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Positive histology of CIN 1-3

        Exclusion Criteria:

          -  Patients with endocervical lesions

          -  Patients with AGUS

          -  Patients with invasive disease

          -  Patients with porphyria

          -  Patients sensitive to MAL and HAL

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter Hillemanns, Md PhD, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00369018

Organization ID

PC CE101/06

Study Sponsor

Photocure

Study Sponsor

Peter Hillemanns, Md PhD, Principal Investigator, Hannover Medical School

Verification Date

November 2010