Trials Sponsors Conditions Drugs Pricing

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 FluidDevice

The tested MD is a very high protection sunscreen

ACTIVE and UNTREATED

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (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),

Sponsors & Collaborators

Centre de Pharmacologie Clinique Applique a la Dermatologie
Otherlead

Study Sites (1)

CPCAD

Nice, Cpcad, 06202, France

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: 35716331DERIVED

Enrollment

15 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

September 17, 2021

First Posted

April 11, 2022

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (1)

ACTIVE and UNTREATED

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (1)

ACTIVE and UNTREATED

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations