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

Primary Purpose

Keratosis, Actinic

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Aktilite® Galderma

PHOS ISTOS PDT

About this trial

This is an interventional treatment trial for Keratosis, Actinic focused on measuring PDT, Methyl Aminolevulinate, light emitting textile

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHRU, Hôpital Claude Huriez
Klinikum Vest Gmbh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional PDT

PHOS ISTOS PDT

Arm Description

Aktilite® Galderma

Light Emitting textile device

Outcomes

Primary Outcome Measures

Treated lesion response rate

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

Secondary Outcome Measures

Visual analog scale of pain

measure the pain and local tolerance graduation range 0 to 10.

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

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

Dermatology Life Quality Index (DLQI )

The questionnaire of 10 questions is completed by the patient to evaluate his quality of life

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

Full Information

NCT ID

NCT03076892

First Posted

March 7, 2017

Last Updated

November 13, 2017

Sponsor

University Hospital, Lille

Collaborators

European Commission, Institut National de la Santé Et de la Recherche Médicale, France

1. Study Identification

Unique Protocol Identification Number

NCT03076892

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

Collaborators

European Commission, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratosis, Actinic

Keywords

PDT, Methyl Aminolevulinate, light emitting textile

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

Split Face intra individual comparison

Masking

None (Open Label)

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional PDT

Arm Type

Active Comparator

Arm Description

Aktilite® Galderma

Arm Title

PHOS ISTOS PDT

Arm Type

Experimental

Arm Description

Light Emitting textile device

Intervention Type

Device

Intervention Name(s)

Aktilite® Galderma

Other Intervention Name(s)

Conventional PDT

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

PHOS ISTOS PDT

Intervention Description

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

Primary Outcome Measure Information:

Title

Treated lesion response rate

Description

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

Time Frame

up to Month 6

Secondary Outcome Measure Information:

Title

Visual analog scale of pain

Description

measure the pain and local tolerance graduation range 0 to 10.

Time Frame

at Day 1 and Day 7

Title

Scale for clinical assessment of the subject's skin aspect

Description

Time Frame

at Month 3 and Month 6

Title

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

Description

Time Frame

at Month 3 and Month 6

Title

Dermatology Life Quality Index (DLQI )

Description

The questionnaire of 10 questions is completed by the patient to evaluate his quality of life

Time Frame

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

Title

Satisfaction autoquestionnaire

Description

Time Frame

at Day 7, Month 3 and Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurent Mortier, MD, PhD

Organizational Affiliation

University Hospital, Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHRU, Hôpital Claude Huriez

City

Lille

ZIP/Postal Code

59045

Country

France

Facility Name

Klinikum Vest Gmbh

City

Recklinghausen

ZIP/Postal Code

45657

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31025953

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.

Results Reference

derived

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

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