MAL DL-PDT and Calcitriol for AK treatment of the upper extremities

Phase 1

• Conditions: Actinic Keratosis; MedDRA version: 21.0Level: HLTClassification code 10020648Term: HyperkeratosesSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-000545-39-IT
• Lead Sponsor: ASL 1 AVEZZANO-SULMONA-L'AQUILA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-25
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

- Patient must provide informed consent documented by signing the ICF prior to any trial-related procedures, following verbal and written information about the trial.
- Subjects (male and female) at least 18 years of age.
- Female subjects must be of either:
a. non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
b. childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy.
Only women of child bearing potential who are willing to adopt highly effective contraceptive measures, can be enrolled in the study.
According to CTFG recommendations highly effective birth control methods include:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal and transdermal;
- progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable and implantable;
- intrauterine device (IUD);
- intrauterine hormone-releasing system (IUS);
- bilateral tubal occlusion;
- vasectomised partner;
- sexual abstinence.
- Subjects with clinically typical, visible and multiple AK lesions (grade I to III), at least 5 in 2 symmetrical areas of each upper extremity (dorsum of the hands or forearms).
- Subjects who are not eligible for the treatment of AK on the upper limbs with alternative therapies (e.g. cryotherapy, diclofenac in hyaluronic acid, ingenol mebutate).

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 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Patients undergoing any of the prohibited therapies within the times listed at point 5.6.
- Organ Transplant Recipient (OTR) patients.
- Lesions in the selected treatment areas that are suspected to be an invasive SCC and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
- History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum, sunburns).
- Clinical diagnosis/history or evidence of any medical condition (e.g. hypercalcemia, abnormal calcium metabolism, systemic treatment of calcium homeostasis, mild to severe renal impairment or end-stage renal disease, liver dysfunction, cutaneous photosensitivity/porphyria, or known allergies to porphyrins, morpheaform basal cell carcinoma) that, as determined by the investigator’s clinical judgment (see SmPC of Silkis® and Metvix®), would be contraindicated for the study treatments, expose a subject to an undue risk of significant AEs, interfere with assessments of safety and efficacy during the course of the trial.
- Patients with known or suspected allergies or hypersensitivities to any component of Silkis®, Metvix® (for both see SmPC) and Cetaphil®.
- Female patients who are pregnant, nursing or planning a pregnancy during the study.
- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this intra-patient, prospective study is to investigate the clearance rate of multiple AKs (grade I to III) on the upper extremities (dorsum of the hand or forearm) treated with 2 sessions of MAL DL-PDT (1 week apart) with or without pre-treatment with calcitriol 1x day for 15 days.;Secondary Objective: NA;Primary end point(s): Complete lesion response rate of AKs defined as the percentage reduction of AK lesions from baseline to follow-up Visit (3 months after the first MAL DL-PDT session).;Timepoint(s) of evaluation of this end point: 3 months after the first MAL DL-PDT session (Visit 3, follow-up).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The per patient response rate of AKs defined as the mean percentage reduction of AKs from baseline to follow-up Visit (3 months after the first MAL DL-PDT session) in each patient; Assessment of patient's pain experienced during each MAL DL-PDT treatment session using 10-point scale VAS. ;Timepoint(s) of evaluation of this end point: 3 months after the first MAL DL-PDT session (Visit 3, follow-up). ; After each session of MAL DL-PDT (Visit 1 and 2).<br>