Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy

Keratosis, Actinic Clinical Trial

— Flexithera  

Official title:

A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03076918
• Other study ID #: 2013_23
• Secondary ID: 2013-A01096-39
• Status: Terminated
• Phase: N/A
• Start date: September 2014
• Est. completion date: February 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic

Intervention

Device:
• FLEXITHERALIGHT PDT
Preparation of lesions, MAL application+occlusive dressing during 30 minutes+illumination 2.5 hours
• Aktilite® Galderma
Preparation of lesions, MAL application+occlusive dressing during 3 hours+illumination 7 to 10 minutes

Locations

Country	Name	City	State
France	CHRU, Hôpital Claude Huriez	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treated lesion response rate	Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed	up to month 6
Secondary	Visual Analog scale of pain	Measure the pain and local tolerance graduation range 0 to 10	Day 1 and D ay 7.
Secondary	Scale for clinical assessment of the subject's skin aspect	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	Months 3 and Months 6
Secondary	Fluorescence measure of the PpIX	Measures with Fluoderm photometer	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.
Secondary	Irradiance measure in mW/cm2 for each AK	Measures realised with a wattmeter OPHIR LaserSTAR to know the power of light delivered	during Aktilite® treatment at Day 1
Secondary	Rate of patients with at least 75% of reduction of the lesions	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	Months 3 and Months 6
Secondary	Dermatology Life Quality Index (DLQI)	The questionnaire of 10 questions is completed by the patient to evaluate his quality of life	At Day 7, Months 3 and Months 6
Secondary	Satisfaction Questionnaire	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	At Day 7, Months 3 and Months 6