Pityriasis Lichenoides : Anatomo-clinical Aspects and Follow-up (EtudePL)

April 15, 2019 updated by: Assistance Publique - Hôpitaux de Paris

Pityriasis Lichenoides: Anatomo-clinical Aspects and Follow-up Monocentric Retrospective Study

Introduction: Pityriasis lichenoides (PL) is an inflammatory dermatitis of undetermined origin consisting of specific papular lesions reflecting an "indolent" lymphoproliferative state.

The current classification is confusing because it mixes semiological and chronological notions.

The objectives of this study are to better describe the clinical, epidemiological, histological, phenotypic and evolutionary aspects of PL in an adult population.

Methods: Investigators will perform a retrospective cohort study including patients with clinical and histological diagnosis of PL from the coding of the Department of Pathology of Henri-Mondor Hospital and from medical records and photographs of lesions if available, between January 2012 and August 2018. A follow-up telephone interviews will also be proposed to each patient to collect evolution data. Photographs will be systematically reviewed as well as cutaneous samples and a genomic analysis will be performed.

Conclusion: Investigators would like to better understand clinical, histological features and evolutionary aspects of PL in an adult population.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with Pityriasis Lichenoides

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with Pityriasis Lichenoides selected from histological coding OT0431, seen at Henri Mondor and with a diagnosis verified from medical records.

Exclusion Criteria:

  • Histological coding error
  • Histological records of patients in care outside Henri Mondor (cases referred for histological expertise only but not seen clinically)
  • Clinical lesions incompatible with Pityriasis Lichenoides according to classically published semiological data
  • Missing or insufficient medical records for data exploitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study clinical Aspects of Pityriasis Lichenoides on a large series of adult patients
Time Frame: It will be measured within 6 months of enrollment
Epidemiological and and clinical aspect description of the lesions from medical charts and photographs: age, sex, suspected trigger of the disease, past medical history, frequency of necrotic lesions, topography of lesions, fever, altered general conditions, treatment modalities of the flare.
It will be measured within 6 months of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study histological features of Pityriasis Lichenoides
Time Frame: It will be measured within 6 months of enrollment
The histological description will make use of a centralized re-reading of the slides according to a standardized grid (appearance of the epidermis, type and topography of the dermal infiltrate, results of the immunolabelings etc ...). The investigators aim to investigate the frequency of patients with patterns of pityriasis lichenoides mimicking lymphomatoid papulosis or mycosis fungoides and to correlate the histological aspect with clinical lesions.
It will be measured within 6 months of enrollment
To study molecular features of Pityriasis Lichenoides
Time Frame: It will be measured within 6 months of enrollment
number of clone T in the skin and in the blood.
It will be measured within 6 months of enrollment
To study the treatment during patients' monitoring
Time Frame: It will be measured within 6 months of enrollment
number of patients with need of a prolonged treatment
It will be measured within 6 months of enrollment
To study the duration of outbreak during patients' monitoring
Time Frame: It will be measured within 6 months of enrollment
the time to healing
It will be measured within 6 months of enrollment
To study the relapse during patients' monitoring
Time Frame: It will be measured within 6 months of enrollment
the number of relapses
It will be measured within 6 months of enrollment
To study the number of outbreaks during patients' monitoring
Time Frame: It will be measured within 6 months of enrollment
the number of outbreaks
It will be measured within 6 months of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Saskia ORO, Doctor, Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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