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Daylight-PDT in the treatment of actinic keratosis: a pilot study comparing two different light sensitizers

Daylight-PDT in the treatment of actinic keratosis: a pilot study comparing two different light sensitizers

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-001389-40-FI
Enrollment
20
Registered
2014-01-14
Start date
2014-04-29
Completion date
Unknown
Last updated
2024-12-03

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

Conditions

actinic keratoses of the scalp MedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Hexvix Product Name: Hexvix Pharmaceutical Form: Cream Trade Name: Metvix Product Name: Metvix Pharmaceutical Form: Cutaneous emulsion

Sponsors

Mari Grönroos
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Actinic keratoses on both sides of scalp or forehead Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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 20

Exclusion criteria

Exclusion criteria: pregnancy lactation

Design outcomes

Primary

MeasureTime frame
Main Objective: Comparing the histological and clinical efficacy of two light sensitizers in the daylight-PDT treatment of actinic keratosis;Secondary Objective: Measuring changes in ppix-formation with hyperspectrum camera;Primary end point(s): clinical and histological healing of actinic keratoses;Timepoint(s) of evaluation of this end point: 3 months after the treatment

Secondary

MeasureTime frame
Secondary end point(s): changes in ppix-formation;Timepoint(s) of evaluation of this end point: before and during treatment

Countries

Finland

Contacts

Public ContactMari Grönroos

Mari Grönroos

mari.gronroos@co.inet.fi

Outcome results

None listed

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