Keratosis, Actinic Clinical Trial
— FlexitheraOfficial title:
A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)
Verified date | May 2018 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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®.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU, Hôpital Claude Huriez | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France |
France,
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 |
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