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Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS

NCT03076892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2017-11-14

No results posted yet for this study

Summary

This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp

Conditions

  • Keratosis, Actinic

Interventions

DEVICE

Aktilite® Galderma

preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes

DEVICE

PHOS ISTOS PDT

preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Laurent Mortier, MD, PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • France
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03076892 on ClinicalTrials.gov