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

NCT03076892 | Completed

• 2 other identifiers: 2015_792016-A00010-51
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 2

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

Conditions

Keratosis, Actinic

Keywords

PDT; Methyl Aminolevulinate; light emitting textile

Outcome Measures

Primary Outcomes (1)

• Treated lesion response rate

  Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed

  up to Month 6

Secondary Outcomes (5)

• Visual analog scale of pain

  at Day 1 and Day 7

• Scale for clinical assessment of the subject's skin aspect

  at Month 3 and Month 6

• Rate of patients with at least 75% of reduction of the lesions

  at Month 3 and Month 6

• Dermatology Life Quality Index (DLQI )

  at day 1 , Day 7, Month 3 and Month 6

• Satisfaction autoquestionnaire

  at Day 7, Month 3 and Month 6

Study Arms (2)

Conventional PDT

ACTIVE COMPARATOR

Aktilite® Galderma

Device: Aktilite® Galderma

PHOS ISTOS PDT

EXPERIMENTAL

Light Emitting textile device

Device: PHOS ISTOS PDT

Interventions

Aktilite® Galderma DEVICE

preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes

Also known as: Conventional PDT

Conventional PDT

PHOS ISTOS PDT DEVICE

preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours

PHOS ISTOS PDT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• European Commission: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

CHRU, Hôpital Claude Huriez

Lille, 59045, France

Location

Klinikum Vest Gmbh

Recklinghausen, 45657, Germany

Location

Related Publications (1)

• 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.

  PMID: 31025953 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

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

Study Officials

• Laurent Mortier, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Split Face intra individual comparison

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 10, 2017
• Study Start: September 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); DE (1)