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Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.


Phase 3
18 Years
N/A
Not Enrolling
Both
Actinic Keratoses

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Trial Information

Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.


Inclusion Criteria:



1. Male or female above 18 years;

2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without
clinical diagnosis of moderate AK on the target areas (TAs);

Exclusion Criteria:

1. Subject with clinical diagnosis of at least one severe AK on TAs

2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin
cancer) on the TAs;

3. Subject with pigmented AK on the TAs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Percent change from baseline in total number of treated mild lesions per side at week 12.

Outcome Description:

At baseline, mild lesions will be mapped on each side. At week 12 each mild lesion response will be assessed per side as: Complete response (Complete disappearance of the lesion, visually and by palpation) Non-complete response (Non-complete disappearance of the lesion) At week 12, the percent change from baseline in number of treated mild lesions per side will be calculated.

Outcome Time Frame:

Baseline and week 12

Safety Issue:

No

Principal Investigator

Stephen Shumack

Investigator Role:

Principal Investigator

Investigator Affiliation:

St George Dermatology and skin Cancer Center

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

RD.03.SPR.29102

NCT ID:

NCT01475071

Start Date:

March 2012

Completion Date:

March 2013

Related Keywords:

  • Actinic Keratoses
  • Keratosis
  • Keratosis, Actinic

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