NCT00708942

Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Photocure · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

Detailed description

Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are. In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	Hexaminolevulinate (HAL)	Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application
DRUG	Placebo	Placebo suppository, for 3-7 hours application
DRUG	Hexaminolevulinate (HAL)	Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application
DRUG	Placebo	Placebo ointment for 5 hours application

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2008-07-03
• Last updated: 2013-04-24
• Results posted: 2013-04-15

Locations

5 sites across 3 countries: France, Germany, Norway