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A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma.


N/A
18 Years
N/A
Open (Enrolling)
Both
Skin Neoplasms, Carcinoma, Basal Cell

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Trial Information

A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma.


Inclusion Criteria:



- male/female above 18 years of age

- written informed consent

- 1 or more primary histologically verified BCC, clinically assessed as of either
superficial of nodular type

Exclusion Criteria:

- pregnancy

- breastfeeding

- Gorlin's syndrome

- porphyria

- xeroderma pigmentosum

- history of arsenic exposure

- known allergy to MAL

- concomitant treatment with immunosuppressive medication

- physical or mental conditions that most likely will prevent patients attending
follow-up sessions

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

lesions response rate

Outcome Description:

Number of lesions in clinical complete response at follow-up

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Magne Børset, PhD prof

Investigator Role:

Study Director

Investigator Affiliation:

Norwegian University of Science and Technology

Authority:

Norway: Regional Ethics Commitee

Study ID:

EC-004

NCT ID:

NCT01482104

Start Date:

June 2012

Completion Date:

June 2016

Related Keywords:

  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Photochemotherapy
  • methyl 5-aminolevulinate
  • Neoplasms
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Basal Cell

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