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

NCT05522036 | Completed

• 1 other identifier: CDR-2022-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Actinic Keratoses

Keywords

Photodynamic Therapy; Actinic Keratoses; White Light; Methyl ALA

Outcome Measures

Primary Outcomes (1)

• Lesion clearance rate

  The number of removed lesions at six-month post treatment will be expressed as percentage: number of removed lesions divided by number of lesions at patients' inclusion.

  1 year

Secondary Outcomes (2)

• Pain & discomfort.

  immediately and 6 days after the procedure

• Crust & erythema

  At 6 days after the procedure

Study Arms (1)

Patients treated with Methy ALA & 35 minutes white light illumination

EXPERIMENTAL

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.

Combination Product: Metvix + Dermaris

Interventions

Metvix + Dermaris COMBINATION_PRODUCT

Photodynamic Therapy

Patients treated with Methy ALA & 35 minutes white light illumination

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Dermatologique du Roy: lead

Study Sites (1)

Centre Dermatologique du Roy

Lasne, Brabant Wallon, 1380, Belgium

Location

Related Publications (1)

• Creusot M, Mordon S. Clinical evaluation of a short illumination duration (1 hour) when performing photodynamic therapy of actinic keratosis using the Dermaris light source. Photodiagnosis Photodyn Ther. 2021 Dec;36:102618. doi: 10.1016/j.pdpdt.2021.102618. Epub 2021 Nov 4.

  PMID: 34743007 RESULT

Related Links

• Clinical site

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: August 30, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual Participant Data (IPD) will be available 6 months after the completion of the clinical study
• Access Criteria: open access journal thanks to a link

Locations

BE (1)