Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ® (Dermaris-35)

Centre Dermatologique du Roy

Status: Completed

Conditions: Actinic Keratoses

Treatments: Combination Product: Metvix + Dermaris

Study type: Interventional

Funder types: Other

Identifiers

NCT05522036

CDR-2022-01

Details and patient eligibility

About

This clinical study aims aims to evaluate the clinical outcomes of SDL-PDT (simulated daylight Photodynamic Therapy) using the Dermaris in patients treated for AK lesions of the scalp at our medical dermatology center using only 35 minutes low-intensity light exposure.

Full description

25 patients, with phototype 1 to 3, with grade I-II AK of the scalp will be treated. Only patients with a minimum of 9 clinically diagnosed grade I and II AK lesions of the scalp (according to the classification of Olsen) suggesting the existence of field cancerization, will treated with SDL-PDT (simulated daylight Photodynamic Therapy) using the Dermaris® (Surgiris, France) and therefore included in the study after application of MAL cream (Metvix ®, Galderma, Switzerland) to the treatment area. After debridment of all treated areas with sandpaper, Metvix will be applied and illuminated with with Dermaris 10 minutes later (leading to drug-light interval (DLI) of 10 minutes) with an irradiance of 2.9 mW/cm2 and a duration of 35 minutes The primary endpoint will be the rate of patients with less than two AK lesions at six-month post-treatment. Secondary endpoints will include scores of pain, erythema, crusts, discomfort and during or/and post the treatment.

A first follow-up visit will be scheduled seven days after the treatment. At this visit, crusts will be clinically rated by a dermatologist, while patients scored discomfort they had experienced during the six-day post-treatment. At the second follow-up visit conducted three months after the treatment, AK lesions will be counted by a dermatologist without differentiation between new and recurrent lesions. A second SDL-PDT using the Dermaris will be performed on the day if AK lesions are still present. At last, in case of remaining AK observed at 6 month follow up, a third treatment session with the same parameters will be carried out.

The study is approved by the Ethical clinical committee of the Centre Dermatologique du Roy and conducted in accordance with the ethical principles of the Declaration of Helsinki (2008) and the International Conference on Harmonisation - Good Clinical Practices and in compliance with local regulatory requirements.

Enrollment: 25 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• phototype 1 to 3,
• grade I-II AK of the scalp
• minimum of 9 clinically diagnosed grade I and II AK lesions of the scalp (according to the classification of Olsen) suggesting the existence of field cancerization

Exclusion criteria

• serious organic disorder,
• incipient or established cognitive impairment
• pregnancy
• lactation,
• to be receiving oral or parenteral pharmacological therapy which might interfere with the results.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Patients treated with Methy ALA & 35 minutes white light illumination

Experimental group

Description:

Only patients with a minimum of 9 clinically diagnosed grade I and II AK lesions of the scalp (according to the classification by Olsen et al. suggesting the existence of field cancerization, are included in the study. All patients are informed about the purpose of the study and gave informed consent before inclusion. The illumination begins 10 min after the application of MAL cream to the treatment area. In this study, the duration of the light exposure is reduced to 35 min to achieve a PpIX-weighted daylight of 4 J/cm2. MAL cream is removed after the illumination procedure leading to an incubation time of 45 min.

Treatment:

Combination Product: Metvix + Dermaris