Clinical trial · Interventional
Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy
A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)
NCT03076918CI-TRIAL-00108872FlexitheracompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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®.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Keratosis, Actinic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aktilite® Galderma | Device | — | UNRESOLVED |
| FLEXITHERALIGHT PDT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional PDT
- description
- Aktilite® Galderma
- interventionNames
- Device: Aktilite® Galderma
- type
- EXPERIMENTAL
- label
- FLEXITHERALIGHT PDT
- description
- Light Emitting Textile Device
- interventionNames
- Device: FLEXITHERALIGHT PDT
Primary outcomes (1)
- measure
- Treated lesion response rate
- timeFrame
- up to month 6
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTVicentini C, Vignion-Dewalle AS, Thecua E, Lecomte F, Maire C, Deleporte P, Behal H, Kerob D, Duhamel A, Mordon S, Mortier L. Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the noninferiority of a new protocol involving irradiation with a light-emitting, fabric-based device (the Flexitheralight protocol) compared with the conventional protocol involving irradiation with the Aktilite CL 128 lamp. Br J Dermatol. 2019 Apr;180(4):765-773. doi: 10.1111/bjd.17350. Epub 2019 Jan 18. PMID 30367470
- DERIVEDLecomte F, Vignion-Dewalle AS, Vicentini C, Thecua E, Deleporte P, Duhamel A, Mordon S, Mortier L. Evaluating the Noninferiority of a New Photodynamic Therapy (Flexitheralight) Compared With Conventional Treatment for Actinic Keratosis: Protocol for a Phase 2 Study. JMIR Res Protoc. 2019 Apr 26;8(4):e11530. doi: 10.2196/11530. PMID 31025952