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

Sponsor
Photocure
Study ID
NCT00369018
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Cervical Dysplasia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Aug 31, 2006
Status verified
Nov 2010
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: MAL 3
  • Active Comparator: MAL 12
  • Active Comparator: HAL 10, 3
  • Active Comparator: HAL 10, 12
  • Active Comparator: HAL 40, 3
  • Active Comparator: HAL 40, 12

Primary Outcome Measure

Lesion eradication [ Time Frame: 6 months ]

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