Protective Effect Assessment of Foto Ultra Isdin Solar Allergy Fusion Fluid on the UVA Induced PLE

NCT05320315 | Completed

• 1 other identifier: ISD-FT-355-01-2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polymorphic Light Eruption

Outcome Measures

Primary Outcomes (1)

• Cumulative number of subjects who don't develop a positive PLE reaction

  Cumulative number of subjects who don't develop a positive PLE reaction (at Day 8)

  Day 8

Secondary Outcomes (2)

• Cumulative number of subjects who don't develop a positive PLE reaction by day

  from Day 1 to Day 8

• PLE severity score

  from Day 1 to Day 8

Other Outcomes (1)

• Colorimetry component a*

  from Day 1 to Day 8

Study Arms (1)

ACTIVE and UNTREATED

OTHER

This was an intraindividual comparison study. Active (DM sunscreen) treated zone and Untreated zone are compared

Device: Foto Ultra ISDIN® Solar Allergy Fusion Fluid

Interventions

Foto Ultra ISDIN® Solar Allergy Fusion Fluid DEVICE

The tested MD is a very high protection sunscreen

ACTIVE and UNTREATED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers of both sexes aged \>18 years with a known history of typical PLE on the chest after intense sun exposure and a last PLE outbreak since at least eight months,
• Subject with Phototype I to IV according to the Fitzpatrick classification (1988) (14),
• Subject in good health having normal results for the physical examination and medical antecedents compatible with the study requirements,
• subject of non-childbearing potential (tubal ligation, hysterectomy, bilateral ovariectomy), or, subject of childbearing potential who has been, in the opinion of the Investigator, using an approved method of birth control (e.g. oral contraception pill or patch, intra-uterine devices, contraceptive implants or vaginal rings, condoms, bilateral tubal ligation) for at least 1 month prior to first visit. Subject must agree to continue adequate contraception during the entire study period and for 1 month after the end of the study,
• Subject who, in the Investigator's opinion, will comply with the requirements of the protocol (e.g., follow protocol instructions, maintain regular contact to allow evaluation during the study),
• Subject agreeing to avoid exposure to UV radiation (tanning beds, phototherapy, and sunlight) on the whole body for at least six months before the screening visit and for the whole duration of the study,
• Subject agreeing to not apply cosmetic, medical or aesthetic treatments out of the study protocol on the chest during the whole study duration,
• Healthy subject registered with Social Security in accordance with French law on interventional research. (Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).

You may not qualify if:

• 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:
• Dermatological active pathologies (e.g. acne, psoriasis, eczema, urticaria...) in particular on the tested area (the chest) or suspicion/antecedents of allergies to cosmetics,
• All systemic or local uncontrolled pathologies,
• S kin anomalies (scars, excessive hair, tattooing…) on the chest,
• 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,
• 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 who has received (or who will receive) more than 4500 euros as indemnity for participating in clinical studies within the previous 12 months.

Sponsors & Collaborators

• Centre de Pharmacologie Clinique Applique a la Dermatologie: lead

Study Sites (1)

CPCAD

Nice, Cpcad, 06202, France

Location

Related Publications (1)

• Duteil L, Queille-Roussel C, Aladren S, Bustos X, Trullas C, Granger C, Krutmann J, Passeron T. Prevention of Polymorphic Light Eruption Afforded by a Very High Broad-Spectrum Protection Sunscreen Containing Ectoin. Dermatol Ther (Heidelb). 2022 Jul;12(7):1603-1613. doi: 10.1007/s13555-022-00755-5. Epub 2022 Jun 18.

  PMID: 35716331 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study was Investigator evaluator blinded. The products were dispensed according to the randomization list by a responsible designated person other than the Investigator evaluator and/or evaluators. The randomization list was masked to the Investigator evaluator during the whole study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, single-blind, randomized, controlled, study with intra-individual comparisons

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: April 11, 2022
• Study Start: February 25, 2021
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)