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Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (Flexithera)

Primary Purpose

Keratosis, Actinic

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FLEXITHERALIGHT PDT
Aktilite® Galderma
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

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.
  • 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 10mm 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, any - Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 3 months.
  • Use of topical retinoids or alpha-hydroxy acids, urea or systemic retinoids, chemotherapy or immunotherapy within 4 weeks of PDT.
  • Pigmented AK lesion(s).
  • Known allergy to Metvixia, 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 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional PDT

FLEXITHERALIGHT 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
Fluorescence measure of the PpIX
Measures with Fluoderm photometer
Irradiance measure in mW/cm2 for each AK
Measures realised with a wattmeter OPHIR LaserSTAR to know the power of light delivered
Rate of patients with at least 75% of reduction of the lesions
The reduction in the number of lesions will be calculated as a function of the initial number:≥4 destroyed if 5 lésions; ≥ 5 destroyed if 6 lésions and ≥6 destroyed if 7 lesions ≥4 destroyed if 5 lesions
Dermatology Life Quality Index (DLQI)
The questionnaire of 10 questions is completed by the patient to evaluate his quality of life
Satisfaction Questionnaire
The questionnaire es created by the investigator to evaluate the comfort of the device. Patient will give his overall satisfaction and the will answer 7 questions on a 5-point scale that ranged from Not embarrassing, few embarrassing, embarrassing, Very embarrassing, I Don't know

Full Information

First Posted
March 7, 2017
Last Updated
May 15, 2018
Sponsor
University Hospital, Lille
Collaborators
National Research Agency, France, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT03076918
Brief Title
Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy
Acronym
Flexithera
Official Title
A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
decision of the investigator in the face of new scientific knowledge
Study Start Date
September 2014 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
National Research Agency, France, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares the efficacy and tolerance of a new device (FLEXITHERALIGHT) for photodynamic therapy in the treatment of keratosis actinic in comparison of classical PDT with Aktilite®.
Detailed Description
The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47 patients. All participants will receive both two treatments in a single visit : a first period of 2.5 hours of illumination with FLEXITHERALIGHT device followed by a continuous red light Spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of methyl aminolevulinate). Patients will complete a pain assessment scale after receiving both treatments, then, 3 follow up visits will be 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 intraindividual comparison
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional PDT
Arm Type
Active Comparator
Arm Description
Aktilite® Galderma
Arm Title
FLEXITHERALIGHT PDT
Arm Type
Experimental
Arm Description
Light Emitting Textile Device
Intervention Type
Device
Intervention Name(s)
FLEXITHERALIGHT PDT
Intervention Description
Preparation of lesions, MAL application+occlusive dressing during 30 minutes+illumination 2.5 hours
Intervention Type
Device
Intervention Name(s)
Aktilite® Galderma
Other Intervention Name(s)
Conventional PDT
Intervention Description
Preparation of lesions, MAL application+occlusive dressing during 3 hours+illumination 7 to 10 minutes
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
Day 1 and D ay 7.
Title
Scale for clinical assessment of the subject's skin aspect
Description
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
Time Frame
Months 3 and Months 6
Title
Fluorescence measure of the PpIX
Description
Measures with Fluoderm photometer
Time Frame
Baseline, after 3 hours of incubation, in case of treatment interruption, immediately after the treatment, and at 15 and 30 minutes after the end of the treatment.
Title
Irradiance measure in mW/cm2 for each AK
Description
Measures realised with a wattmeter OPHIR LaserSTAR to know the power of light delivered
Time Frame
during Aktilite® treatment at Day 1
Title
Rate of patients with at least 75% of reduction of the lesions
Description
The reduction in the number of lesions will be calculated as a function of the initial number:≥4 destroyed if 5 lésions; ≥ 5 destroyed if 6 lésions and ≥6 destroyed if 7 lesions ≥4 destroyed if 5 lesions
Time Frame
Months 3 and Months 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 7, Months 3 and Months 6
Title
Satisfaction Questionnaire
Description
The questionnaire es created by the investigator to evaluate the comfort of the device. Patient will give his overall satisfaction and the will answer 7 questions on a 5-point scale that ranged from Not embarrassing, few embarrassing, embarrassing, Very embarrassing, I Don't know
Time Frame
At Day 7, Months 3 and Months 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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 10mm 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, any - Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 3 months. Use of topical retinoids or alpha-hydroxy acids, urea or systemic retinoids, chemotherapy or immunotherapy within 4 weeks of PDT. Pigmented AK lesion(s). Known allergy to Metvixia, 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 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
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31025952
Citation
Lecomte F, Vignion-Dewalle AS, Vicentini C, Thecua E, Deleporte P, Duhamel A, Mordon S, Mortier L. Evaluating the Noninferiority of a New Photodynamic Therapy (Flexitheralight) Compared With Conventional Treatment for Actinic Keratosis: Protocol for a Phase 2 Study. JMIR Res Protoc. 2019 Apr 26;8(4):e11530. doi: 10.2196/11530.
Results Reference
derived

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Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy

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