Clinical Trial: Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitises: HAL and BF-200 ALA Versus MAL

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitises: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate

Brief Summary: This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.

Detailed Summary: Study recruits volunteering patients, who are referred to the department of dermatology and allergology, Päijät-Häme Central Hospital, Lahti, with 99 clinically assessed superficial basal cell carcinoma on the body area, not face and scalp. Diagnoses is confirmed histologically by punch biopsies and hyperspectral images are taken before the biopsies. The lesions are randomised in three groups: interventions HAL and BF-200 ALA and comparator MAL. Photodynamic therapy is given by the standard procedure. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up, with Wood's light, digital camera and a yellow lens, before and after the exposure. Pain is measured in VAS-scale before, during and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
Sponsor: Joint Authority for Päijät-Häme Social and Health Care

Current Primary Outcome:

  • Histological lesion clearance [ Time Frame: 3 months ]
  • Histological lesion clearance [ Time Frame: 12 months ]
  • Histological lesion clearance [ Time Frame: 5 years ]


Original Primary Outcome:

  • Histological lesion clearance [ Time Frame: 3 months ]
  • Histological lesion clearance [ Time Frame: 12 months ]


Current Secondary Outcome:

  • Detection of subclinical lesion with hyperspectral imaging system [ Time Frame: 3 months ]
  • Detection of subclinical lesion with hyperspectral imaging system [ Time Frame: 12 months ]
  • Detection of subclinical lesion with hyperspectral imaging system [ Time Frame: 5 years ]


Original Secondary Outcome:

  • Detection of subclinical lesion with hyperspectral imaging system [ Time Frame: 3 months ]
  • Detection of subclinical lesion with hyperspectral imaging system [ Time Frame: 12 months ]


Information By: Joint Authority for Päijät-Häme Social and Health Care

Dates:
Date Received: January 31, 2015
Date Started: March 2015
Date Completion: December 2022
Last Updated: September 8, 2016
Last Verified: September 2016