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

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: NCT03076892
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborators:
European Commission
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 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

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Split Face intra individual comparison
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017
Arms and Interventions
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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 Name: 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


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: at Day 1 and Day 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: at Month 3 and Month 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. Rate of patients with at least 75% of reduction of the lesions [ Time Frame: at Month 3 and Month 6 ]
    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

  4. Dermatology Life Quality Index (DLQI ) [ Time Frame: at day 1 , Day 7, Month 3 and Month 6 ]
    The questionnaire of 10 questions is completed by the patient to evaluate his quality of life

  5. Satisfaction autoquestionnaire [ Time Frame: at Day 7, Month 3 and Month 6 ]

    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



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.
  • 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.
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): NCT03076892


Locations
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France
CHRU, Hôpital Claude Huriez
Lille, France, 59045
Germany
Klinikum Vest Gmbh
Recklinghausen, Germany, 45657
Sponsors and Collaborators
University Hospital, Lille
European Commission
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: NCT03076892    
Other Study ID Numbers: 2015_79
2016-A00010-51 ( Other Identifier: ID-RCB number, ANSM )
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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