Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (NCT03076918) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy
France29 participantsStarted 2014-09
Plain-language 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 AktiliteĀ®.
Who can participate
Age range18 Years
SexALL
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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 moā¦