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Keratosis, ActinicFlexitheraNCT03076918

Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy

A study testing FLEXITHERALIGHT PDT and Aktilite® Galderma in people with Keratosis, Actinic, run by University Hospital, Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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®. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Keratosis, Actinic
What is being tested?
FLEXITHERALIGHT PDT and Aktilite® Galderma
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteFrance
Study dates
Sep 2014to Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHRU, Hôpital Claude Huriez

    Lille

Other trials in France

About this study

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

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®.

Read the detailed 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.

Being tested
FLEXITHERALIGHT PDT, Aktilite® Galderma
Keywords
PDT, Methyl Aminolevulinate, Light Emitting Textile
Medical subject headings
Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FLEXITHERALIGHT PDTDevice

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

  • Aktilite® GaldermaDevice

    Also called Conventional PDT

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

Study groups in NCT03076918
Study groupRoleWhat they receive
Conventional PDTActive comparatorAktilite® Galderma
Receives: Device: Aktilite® Galderma
FLEXITHERALIGHT PDTExperimentalLight Emitting Textile Device
Receives: Device: FLEXITHERALIGHT PDT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treated lesion response rate

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

    Measured: up to month 6

Secondary outcomes (7)

  1. Visual Analog scale of pain

    Measure the pain and local tolerance graduation range 0 to 10

    Measured: Day 1 and D ay 7.

  2. 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

    Measured: Months 3 and Months 6

  3. Fluorescence measure of the PpIX

    Measures with Fluoderm photometer

    Measured: 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.

  4. Irradiance measure in mW/cm2 for each AK

    Measures realised with a wattmeter OPHIR LaserSTAR to know the power of light delivered

    Measured: during Aktilite® treatment at Day 1

  5. 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

    Measured: Months 3 and Months 6

  6. Dermatology Life Quality Index (DLQI)

    The questionnaire of 10 questions is completed by the patient to evaluate his quality of life

    Measured: At Day 7, Months 3 and Months 6

  7. 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

    Measured: At Day 7, Months 3 and Months 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2017
  2. Study startSep 2014
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Split face intraindividual comparison
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03076918
Sponsor's protocol ID
2013_23
Other IDs
2013-A01096-39
Acronym
Flexithera
Status last verified
Apr 2026
First submitted
7 Mar 2017
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30367470

  • 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.

    PubMed 31025952

Questions about this trial

What is this clinical trial studying?

A study testing FLEXITHERALIGHT PDT and Aktilite® Galderma in people with Keratosis, Actinic, run by University Hospital, Lille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treated lesion response rate (time frame: up to month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03076918, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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