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

• ClinicalTrials.gov Identifier: NCT03076892
• Recruitment Status: Completed
• First Posted: March 10, 2017
• Last Update Posted: November 14, 2017
• Sponsor: University Hospital, Lille
• 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: March 7, 2017
• First Posted Date: March 10, 2017
• Last Update Posted Date: November 14, 2017
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Evaluation of Non-inferiority and Tolerability of the Device 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)
• 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Split Face intra individual comparison

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Keratosis, Actinic

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 9, 2017): 47
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2017
• Actual Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany

Administrative Information

• NCT Number: NCT03076892
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: University Hospital, Lille
• Study Sponsor: University Hospital, Lille

Collaborators

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

Investigators

• Principal Investigator: Laurent Mortier, MD, PhD; University Hospital, Lille

• PRS Account: University Hospital, Lille
• Verification Date: November 2017