Treatment of precursors to skin cancer with photodynamic therapy using a halogen lamp

Phase 1

Conditions: Actinic keratoses
MedDRA version: 16.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2013-005438-39-DK

Lead Sponsor: Department of Dermatology D92, Bispebjerg Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Scandinaivan ancestory
Healthy individuals
Actinic keratoses in forehead or scalp
18 years old og older
Infomed written and oral consent
No nevi, tatoos or scars in the treated areas
Fertile women have to use safe contraceptive measures
Medical record with regards to medical treatment is mandatory before inclusion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

Allergy to Methyl-ALA
·Vacation in a sunny environment or use og sunbed within last 4 weeks.
Relevant active skin disease in treatment area
·Decreased skin sensitivity, like neuropathy
·Pregnancy or breastfeeding
·Concurrent participation in other clinical trials
·Patients thought not to be able to follow protocol ie patients with dementia, psychiatric illnesses, alcoholics

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of indoor pulse photodynamic therapy in the treatment of actinic keratoses with a halogen lamp;Secondary Objective: To investigate the following:<br>Failure rate (recurrence)<br>Pain during treatment<br>Adverse effects: Scaring, hypo- and hyperpigmentation, erythema<br>Cosmetic outcome<br>Effect of the halogen lamp to activate PpIX in normal skin;Primary end point(s): Clearance rate 3 months after treatment. It is assessed whether the lesion is completely disappeared after treatment(complete response) or not completely disappeared (non-complete response) ;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Failure rate (recurrence)<br>Pain during photodynamic therapy<br>Adverse effect: scaring, hypo- and hyperpigmentation, erythema <br>Cosmetic outcome<br>Effect of the halogen lamp to activate PpIX in normal skin;Timepoint(s) of evaluation of this end point: Failure rate (relapse) : 6 and 12 months<br>Pain during photodynamic therapy: every 30 minutes during exposure to light and 4 different timepoints the day after treatment<br>Adverse effect: erythema and wound - 2 days after treatment<br>Scarring, hyper and hypopigmentation: 3, 6 and 12 months after treatment<br>Cosmetic outcome: 3 and 12 months after treatment<br>Effect of the halogen lamp: imediately after exposure to light ie 2 hours