Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy

Not Applicable

Terminated

• Conditions: Keratosis, Actinic
• Interventions: Device: FLEXITHERALIGHT PDT; Device: Aktilite® Galderma

• Registration Number: NCT03076918
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
FLEXITHERALIGHT PDT	FLEXITHERALIGHT PDT	Light Emitting Textile Device
Conventional PDT	Aktilite® Galderma	Aktilite® Galderma

Primary Outcome Measures

Name	Time	Method
Treated lesion response rate	up to month 6	Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed

Secondary Outcome Measures

Name	Time	Method
Visual Analog scale of pain	Day 1 and D ay 7.	Measure the pain and local tolerance graduation range 0 to 10
Fluorescence measure of the PpIX	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
Rate of patients with at least 75% of reduction of the lesions	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
Scale for clinical assessment of the subject's skin aspect	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
Irradiance measure in mW/cm2 for each AK	during Aktilite® treatment at Day 1	Measures realised with a wattmeter OPHIR LaserSTAR to know the power of light delivered
Dermatology Life Quality Index (DLQI)	At Day 7, Months 3 and Months 6	The questionnaire of 10 questions is completed by the patient to evaluate his quality of life
Satisfaction Questionnaire	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

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France