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The primary objective of this Clinical Investigation was to assess the protective efficacy of a medical device (FOTO ULTRA ISDIN® SOLAR ALLERGY FUSION FLUID) against the polymorphic light eruption induced by the UVA.
The secondary objective of this Clinical Investigation was to assess the local safety and the overall tolerability of the test MD on the basis of AE/SAE reporting.
Full description
This was a PMCF investigation for a MD CE marked and used in its intended purpose with additional procedure non-invasive or non-burdensome.
This was a monocentric, single-blind, randomized, and controlled study performed with intra-individual comparisons. It is a type 2 Interventional study with minimal risks and constraints.
At least Fifteen (15) subjects with a known history of typical PLE on the chest after intense sun exposure were included in the study. The subjects were recruited via the CPCAD Subject Database or from those who spontaneously come to the CPCAD.
At Day 1, the tested MD was applied (2mg/cm²) on on side (10x15cm area) of the chest of each subject. The other side was not treated. Then, 15 minutes after application, both sides were irradiated with 40L/cm² of UVA. Same procedure was used from Day 2 to Day 5 with inceased UVA dose at Day 3 and Day 4 (50J/cm²) and Day 5 (60J/cm²).
UVA exposures have to be stopped once a PLE reaction was induced. Assessments (clinical, colorimetrical and photographs) were performed each day. Last assessments were perfomed at Day 8.
Enrollment
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Inclusion criteria
Exclusion criteria
Female subject who is pregnant, parturient or breast feeding,
Subject of childbearing potential having a positive urinary pregnancy test at Day 1,
Subject has a PLE outbreak in the past eight months,
Subject has a medical condition or is taking medication that could put him or her at undue risk,
Subject has a pathology that is unstable or risks interfering with the study,
Subject is currently receiving treatment that may interfere with interpretation of the study results,
Subject has known or suspected allergies or sensitivities to any of the components of the study product,
Subjects with an underlying pathology, or with a surgical, physical or medical status which, according to the investigator, could interfere with the interpretation of the study results such as:
Subjects having been exposed to ultraviolet radiation (UV), natural (sun) or artificial (tanning salon), in the 6 months before the initial visit or who plans such an exposure during the study,
Subjects having taken a systemic treatment, able to induce an abnormal response to UV, for more than 5 days during the month preceding inclusion (steroids, non-steroidal anti-inflammatories such as aspirin, insulin, antihistamines, anti-hypertensives, antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all other photosensitising treatments) or all treatments capable of inducing an abnormal response to UV (vitamin A derivatives, psoralen, aminolevulinic acid derivatives...) or planning to take these treatments during the study,
Subjects having applied a local treatment on the chest for more than 2 days during the 2 weeks preceding inclusion (steroids, non-steroidal anti-inflammatories, antihistamines, antibiotics) and all other cosmetic products in the previous 24 hours,
Protected subject as defined in the Articles of the CSP: Article 1121-7: person deprived of liberty by a judicial or administrative decision, or subject to psychiatric care or person admitted to a health or social institution for purposes other than the research. Article 1121-8: adult person subject to a legal protection measure or unable to express his/her consent.
Subject unable to communicate or cooperate with the Investigator due to poor mental development, language problems or impaired cerebral function,
Subject currently participating in another clinical study related to pharmaceuticals or MDs or being in an exclusion period of another clinical study,
Subject who has received (or who will receive) more than 4500 euros as indemnity for participating in clinical studies within the previous 12 months.
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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