A Randomised Double Blind Comparative Study of Pain During and After MAL or 5-ALA Photodynamic Therapy - MAL/ALA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005171-14-GB

Enrollment

Registered

2007-10-10

Start date

2008-01-07

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Bowen's disease (sqaumous cell carcinoma in-situ) and actinic keratoses MedDRA version: 9.1 Level: LLT Classification code 10000614 Term: Actinic keratosis

Interventions

Trade Name: Metvix Pharmaceutical Form: Cream Current Sponsor code: MAL Other descriptive name: methyl aminolevulinate hydrochloride Concentration unit: % (W/W) percent weight/weight Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with histologically-confirmed BD, equal to or less than 3 cm in diameter, and patients with a clinical diagnosis of non-hypertrophic AK will elligible for recruitment to the study. Patients must be Caucasian, between 18 and 80 years of age and must be capable of giving informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Lesions previously treated by any means will be excluded.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Patient satisfaction,fluorescence, phototoxicity and clinical outcome will also be examined. We will also examine the correlation between pain response and genetically determined differences in how individual patients respond to pain. ;Primary end point(s): The primary endpoint of this study is to compare the pain of MAL and ALA PDT for BD and AK. The primary outcome measures will be the pain score immediately post treatment. ;Main Objective: To assess pain scores to one of the two randomly assigned study drugs.	—

Measure

Time frame

Secondary Objective: Patient satisfaction,fluorescence, phototoxicity and clinical outcome will also be examined. We will also examine the correlation between pain response and genetically determined differences in how individual patients respond to pain. ;Primary end point(s): The primary endpoint of this study is to compare the pain of MAL and ALA PDT for BD and AK. The primary outcome measures will be the pain score immediately post treatment. ;Main Objective: To assess pain scores to one of the two randomly assigned study drugs.

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Countries

United Kingdom

Outcome results

None listed

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