Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy

NCT03076918 | Completed

• 2 other identifiers: 2013_232013-A01096-39
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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®.

Conditions

Keratosis, Actinic

Keywords

PDT, Methyl Aminolevulinate, Light Emitting Textile

Outcome Measures

Primary Outcomes (1)

• Treated lesion response rate

  Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed

  up to month 6

Secondary Outcomes (7)

• Visual Analog scale of pain

  Day 1 and D ay 7.

• Scale for clinical assessment of the subject's skin aspect

  Months 3 and Months 6

• 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.

• Irradiance measure in mW/cm2 for each AK

  during Aktilite® treatment at Day 1

• Rate of patients with at least 75% of reduction of the lesions

  Months 3 and Months 6

Study Arms (2)

Conventional PDT

ACTIVE COMPARATOR

Aktilite® Galderma

Device: Aktilite® Galderma

FLEXITHERALIGHT PDT

EXPERIMENTAL

Light Emitting Textile Device

Device: FLEXITHERALIGHT PDT

Interventions

FLEXITHERALIGHT PDT DEVICE

Preparation of lesions, MAL application+occlusive dressing during 30 minutes+illumination 2.5 hours

FLEXITHERALIGHT PDT

Aktilite® Galderma DEVICE

Preparation of lesions, MAL application+occlusive dressing during 3 hours+illumination 7 to 10 minutes

Also known as: Conventional PDT

Conventional PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• National Research Agency, France: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

Related Publications (2)

• Vicentini 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 RESULT

• Lecomte 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 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laurent Mortier, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split face intraindividual comparison

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 10, 2017
• Study Start: September 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)