Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS (PHOS-ISTOS)

A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)

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

Study Overview

• Status: Completed
• Conditions: Keratosis, Actinic
• Intervention / Treatment: Device: Aktilite® Galderma; Device: PHOS ISTOS PDT

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

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59045
    • CHRU, Hôpital Claude HURIEZ
• Germany
  • Recklinghausen, Germany, 45657
    • Klinikum Vest GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional PDT; Aktilite® Galderma	Device: Aktilite® Galderma; preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes; Other Names: Conventional PDT
Experimental: PHOS ISTOS PDT; Light Emitting textile device	Device: PHOS ISTOS PDT; preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treated lesion response rate	Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed	up to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale of pain	measure the pain and local tolerance graduation range 0 to 10.	at Day 1 and Day 7
Scale for clinical assessment of the subject's skin aspect	4-point scale that ranged of Excellent :No scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared to adjacent skin Good: No scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin Fair: Slight to moderate occurrence of scarring, atrophy or induration Poor : Extensive occurrence of scarring, atrophy or induration	at Month 3 and Month 6
Rate of patients with at least 75% of reduction of the lesions	The response rate is calculated in relation to the initial number of lesions: Response rate is validated if rate ≥ 4 lesions destroyed for 5 initial lesions, ≥ 5 for 6 lesions and ≥ 6 for 7 lesions	at Month 3 and Month 6
Dermatology Life Quality Index (DLQI )	The questionnaire of 10 questions is completed by the patient to evaluate his quality of life	at day 1 , Day 7, Month 3 and Month 6
Satisfaction autoquestionnaire	The questionnaire is created by investigator to evaluate the comfort of device. Participants will answer 9 questions on a 5-point scale that ranged from Not embarrassing,few embarrassing, Embarrassing, Very embarrassing, Don't know	at Day 7, Month 3 and Month 6

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; European Commission

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: PDT; Methyl Aminolevulinate; light emitting textile
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: 2015_79; 2016-A00010-51 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No