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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076918
Recruitment Status : Terminated (decision of the investigator in the face of new scientific knowledge)
First Posted : March 10, 2017
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
National Research Agency, France
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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®.

Condition or disease Intervention/treatment Phase
Keratosis, Actinic Device: FLEXITHERALIGHT PDT Device: Aktilite® Galderma Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Split face intraindividual comparison
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)
Actual Study Start Date : September 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Conventional PDT
Aktilite® Galderma
 Device: Aktilite® Galderma
Preparation of lesions, MAL application+occlusive dressing during 3 hours+illumination 7 to 10 minutes
Other Name: Conventional PDT
Experimental: FLEXITHERALIGHT PDT
Light Emitting Textile Device
 Device: FLEXITHERALIGHT PDT
Preparation of lesions, MAL application+occlusive dressing during 30 minutes+illumination 2.5 hours


Outcome Measures
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Primary Outcome Measures :
  1. Treated lesion response rate [ Time Frame: up to month 6 ]
    Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed


Secondary Outcome Measures :
  1. Visual Analog scale of pain [ Time Frame: Day 1 and D ay 7. ]
    Measure the pain and local tolerance graduation range 0 to 10

  2. Scale for clinical assessment of the subject's skin aspect [ Time Frame: Months 3 and Months 6 ]
    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

  3. Fluorescence measure of the PpIX [ 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. ]
    Measures with Fluoderm photometer

  4. Irradiance measure in mW/cm2 for each AK [ Time Frame: during Aktilite® treatment at Day 1 ]
    Measures realised with a wattmeter OPHIR LaserSTAR to know the power of light delivered

  5. Rate of patients with at least 75% of reduction of the lesions [ Time Frame: Months 3 and Months 6 ]

    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


  6. Dermatology Life Quality Index (DLQI) [ Time Frame: At Day 7, Months 3 and Months 6 ]
    The questionnaire of 10 questions is completed by the patient to evaluate his quality of life

  7. Satisfaction Questionnaire [ Time Frame: At Day 7, Months 3 and Months 6 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076918


Locations
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France
CHRU, Hôpital Claude Huriez
Lille, France
Sponsors and Collaborators
University Hospital, Lille
National Research Agency, France
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Laurent Mortier, MD, PhD University Hospital, Lille
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03076918    
Other Study ID Numbers: 2013_23
2013-A01096-39 ( Other Identifier: ID-RCB number, ANSM )
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
PDT, Methyl Aminolevulinate, Light Emitting Textile
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms