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

Pulse photodynamic therapy with methyl aminolevulinate activated by a halogen lamp

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005438-39-DK

Enrollment

Unknown

Registered

2014-03-17

Start date

2014-04-01

Completion date

Unknown

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic keratoses MedDRA version: 16.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Metvix Pharmaceutical Form: Cream INN or Proposed INN: Methyl aminolevulinate Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE Concentration unit: mg/g milligram(s)/gram Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: Failure rate (recurrence) Pain during treatment Adverse effects: Scaring, hypo- and hyperpigmentation, erythema Cosmetic outcome 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	—

Measure

Time frame

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: Failure rate (recurrence) Pain during treatment Adverse effects: Scaring, hypo- and hyperpigmentation, erythema Cosmetic outcome 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

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Secondary

Measure	Time frame
Secondary end point(s): Failure rate (recurrence) Pain during photodynamic therapy Adverse effect: scaring, hypo- and hyperpigmentation, erythema Cosmetic outcome 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 Pain during photodynamic therapy: every 30 minutes during exposure to light and 4 different timepoints the day after treatment Adverse effect: erythema and wound - 2 days after treatment Scarring, hyper and hypopigmentation: 3, 6 and 12 months after treatment Cosmetic outcome: 3 and 12 months after treatment Effect of the halogen lamp: imediately after exposure to light ie 2 hours	—

Measure

Time frame

Secondary end point(s): Failure rate (recurrence) Pain during photodynamic therapy Adverse effect: scaring, hypo- and hyperpigmentation, erythema Cosmetic outcome 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 Pain during photodynamic therapy: every 30 minutes during exposure to light and 4 different timepoints the day after treatment Adverse effect: erythema and wound - 2 days after treatment Scarring, hyper and hypopigmentation: 3, 6 and 12 months after treatment Cosmetic outcome: 3 and 12 months after treatment Effect of the halogen lamp: imediately after exposure to light ie 2 hours

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Countries

Denmark

Contacts

Public ContactDepartment of Dermatology

Bispebjerg Hospital

Hans.Christian.Olsen.Wulf@regionh.dk00453531 3155

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026