Daylight photodynamic therapy (DL-PDT) in the treatment of actinic keratosis on the face and scalp carried out with two different skin preparation modalities

Evaluation of efficacy, safety and patient¿s satisfaction of daylight photodynamic therapy (DL-PDT) in the treatment of actinic keratosis on the face and scalp and related field cancerization carried out with two different skin preparation modalities - Daylight photodynamic therapy (DL-PDT) in the treatment of actinic keratosis on the face and scalp c

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000490-20-IT

Enrollment

Registered

2021-06-08

Start date

2018-02-08

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

actinic keratosis MedDRA version: 21.1 Level: LLT Classification code 10064679 Term: Basal cell carcinoma of skin in situ System Organ Class: 100000004864 MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0 Level: LLT Classification code 10064266 Term: Skin hemorrhage System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adult patients with AK lesions on face or scalp (at least 3 AKs on scalp, forehead or cheek) • AKs of grade I to II • 18 Years and older 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • Previous treatment for AKs on the same skin area during preceding 6 months • Porphyria or solar dermatitis • Morpheaform BCC • Allergy for photosensitizers used in the study • Pregnant or breastfeeding patients • Impaired general condition (patient can't manage required 2 hours in sunlight outdoors)

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study to evaluate and compare efficacy (based on clinical, dermoscopic and confocal assessments), safety and patient¿s satisfaction of DL-PDT in the treatment of AKs on the face and scalp and related field cancerization carried out with two different skin preparation modalities. ;Secondary Objective: Patient compliance and assessment of safety and local tolerability to treatment. ;Primary end point(s): •Total count of AKs before and after treatment [Time Frame: baseline and week 13]. AKs in the treatment areas are counted, categorized clinically in three grades I-III (Olsen et al. 1991), and examined dermoscopically and confocally before DL-PDT treatment. The response to treatment will be assessed clinically, dermoscopically and confocally on week 13. •Patient satisfaction assessed by a questionnaire [Time Frame: weeks 2 and 13]. Patients will be asked to fill 5-point Likert scale about satisfaction to treatment .;Timepoint(s) of evaluation of this end point: 13 weeks	—

Measure

Time frame

Main Objective: The main objective of this study to evaluate and compare efficacy (based on clinical, dermoscopic and confocal assessments), safety and patient¿s satisfaction of DL-PDT in the treatment of AKs on the face and scalp and related field cancerization carried out with two different skin preparation modalities. ;Secondary Objective: Patient compliance and assessment of safety and local tolerability to treatment. ;Primary end point(s): •Total count of AKs before and after treatment [Time Frame: baseline and week 13]. AKs in the treatment areas are counted, categorized clinically in three grades I-III (Olsen et al. 1991), and examined dermoscopically and confocally before DL-PDT treatment. The response to treatment will be assessed clinically, dermoscopically and confocally on week 13. •Patient satisfaction assessed by a questionnaire [Time Frame: weeks 2 and 13]. Patients will be asked to fill 5-point Likert scale about satisfaction to treatment .;Timepoint(s) of evaluation of this end point: 13 weeks

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Secondary

Measure	Time frame
Secondary end point(s): ¿ Assessing pain experienced by patients [Time Frame: weeks 1 and 2]. Patients will be asked to fill visual analogue scales (VAS) about pain experienced during the treatment. ¿ Assessing safety and primary treatment reaction of skin [Time Frame: weeks 1 and 2]. Patients will be evaluated after treatment for evaluation of skin reaction (erythema, scaling, pigmentation, follicular plugs) on a scale ranging from 0 (no reaction) to 4 (very severe reaction). Primary treatment reaction of skin will be assessed after the DL-PDT treatment. ;Timepoint(s) of evaluation of this end point: week 1 and 2	—

Measure

Time frame

Secondary end point(s): ¿ Assessing pain experienced by patients [Time Frame: weeks 1 and 2]. Patients will be asked to fill visual analogue scales (VAS) about pain experienced during the treatment. ¿ Assessing safety and primary treatment reaction of skin [Time Frame: weeks 1 and 2]. Patients will be evaluated after treatment for evaluation of skin reaction (erythema, scaling, pigmentation, follicular plugs) on a scale ranging from 0 (no reaction) to 4 (very severe reaction). Primary treatment reaction of skin will be assessed after the DL-PDT treatment. ;Timepoint(s) of evaluation of this end point: week 1 and 2

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Countries

Italy

Contacts

Public ContactClinica Dermatologica

Reparto di Dermatologia- Seconda Universit¿ degli Studi di Napoli

dermosun@gmail.com0815666828

Outcome results

None listed

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