New light device aims to ease pain of skin spot treatment
NCT ID NCT03076918
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new device called Flexitheralight against the usual light therapy for actinic keratosis, which are rough spots caused by sun damage. About 29 adults with at least 10 spots on their forehead or scalp took part. The goal was to see if the new device works just as well but causes less pain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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29 people
The number who actually took part.
- Started
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Sep 2014
- Finished
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Feb 2017
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHRU, Hôpital Claude Huriez
Lille, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.