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

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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

Tracking Information
First Submitted Date  ICMJE March 7, 2017
First Posted Date  ICMJE March 10, 2017
Last Update Posted Date November 14, 2017
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • Visual analog scale of pain [ Time Frame: at Day 1 and Day 7 ]
    measure the pain and local tolerance graduation range 0 to 10.
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
  • Visual analog scale of pain [ Time Frame: at Day 1 and Day 7 ]
    measure the pain and local tolerance graduation range 0 to 10.
  • 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
  • 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
  • Dermatology Life Quality Index (DLQI ) [ Time Frame: at Day 7, Month 3 and Month 6 ]
    The questionnaire of 10 questions is completed by the patient to evaluate his quality of life
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS
Official Title  ICMJE A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Split Face intra individual comparison
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Keratosis, Actinic
Intervention  ICMJE
  • Device: Aktilite® Galderma
    preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes
    Other Name: Conventional PDT
  • Device: PHOS ISTOS PDT
    preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours
Study Arms  ICMJE
  • Active Comparator: Conventional PDT
    Aktilite® Galderma
    Intervention: Device: Aktilite® Galderma
  • Experimental: PHOS ISTOS PDT
    Light Emitting textile device
    Intervention: Device: PHOS ISTOS PDT
Publications * Vignion-Dewalle AS, Abi Rached H, Thecua E, Lecomte F, Deleporte P, Béhal 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2017)
47
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03076892
Other Study ID Numbers  ICMJE 2015_79
2016-A00010-51 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE
  • European Commission
  • Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: Laurent Mortier, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP