Clinical trial NCT03076892: Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS
Official title: A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratosis, Actinic
Keywords: PDT
Methyl Aminolevulinate
light emitting textile
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: European Commission
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-03-10
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Split Face intra individual comparison
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp

Detailed description: The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47. Patients will receive both treatments in a single visit: A first period of 2.5 hours of illumination with Phos-Istos device followed by a continuous red light spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of MAL (methyl aminolevulinate). Patients will complete a pain assessment scale after receiving both treatments. 3 follow-up visits will be then scheduled

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of minimum 10 previously untreated not pigmented, non-hyperkeratotic AK lesions of Grade I and II of the forehead and/or scalp (according to Olsen et Al. JAAD 1991, cf. REF 31) where other therapies are unacceptable or considered medically less appropriate with a symmetrical repartition on both side of the forehead and/or scalp. The diagnosis of AK will be determined upon clinical evaluation (i.e. visual inspection and palpation) by the investigator.
* No treatment for the AKs in the previous 30 days.
* Symmetrical areas in terms of number and severity of lesions. The axis of symmetry between the two areas will be defined by the investigator according to the distribution of lesions.
* The two areas to be treated should not be coalescing. A minimum distance of 10 mm is required between the lesions located on the 2 symmetrical areas. A minimum distance of 2 mm is required between the lesions on the same side.
* Minimum 5 lesions with similar dimensions at both symmetrical areas will be treated. If the number of lesions is \>7, only 7 lesions on each side will be considered.

Exclusion Criteria:

* Patients with porphyria.
* Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
* Use of topical corticosteroids to lesional areas within 2 weeks before PDT.
* Patients receiving local treatment (including cryotherapy and curettage-electrocoagulation, any PDT treatment) in face / scalp area within the last 30 days.
* Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 30 days.in
* Use of topical retinoids or alpha-hydroxy acids, systemic retinoids, chemotherapy or immunotherapy within 30 days of PDT.
* Pigmented AK lesion(s).
* Known allergy to Metvixia/Metvix, a similar PDT compound or excipients of the cream including arachis oil, or to peanut or soya.
* Participation in other clinical studies either currently or within the last 30 days.
* Female subjects must be of either:

  * Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
  * Childbearing potential, provided there is a confirmed negative urine pregnancy test or blood analysis prior to study treatment, to rule out pregnancy.
* Any condition which may be associated with a risk of poor protocol compliance.
* Patients currently receiving regular ultraviolet radiation therapy.

Primary outcomes:
measure: Treated lesion response rate
timeFrame: up to Month 6
Secondary outcomes:
measure: Visual analog scale of pain
timeFrame: at Day 1 and Day 7
measure: Scale for clinical assessment of the subject's skin aspect
timeFrame: at Month 3 and Month 6
measure: Rate of patients with at least 75% of reduction of the lesions
timeFrame: at Month 3 and Month 6
measure: Dermatology Life Quality Index (DLQI )
timeFrame: at day 1 , Day 7, Month 3 and Month 6
measure: Satisfaction autoquestionnaire
timeFrame: at Day 7, Month 3 and Month 6
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
city: Recklinghausen
country: Germany
facility: Klinikum Vest Gmbh
Study officials:
affiliation: University Hospital, Lille
name: Laurent Mortier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vignion-Dewalle AS, Abi Rached H, Thecua E, Lecomte F, Deleporte P, Behal H, Hommel T, Duhamel A, Szeimies RM, Mortier L, Mordon S. A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study). JMIR Res Protoc. 2019 Apr 26;8(4):e12990. doi: 10.2196/12990.