Pityriasis LichenoidesEtudePLNCT03920696
Pityriasis Lichenoides : Anatomo-clinical Aspects and Follow-up
An observational study of Pityriasis Lichenoides, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pityriasis Lichenoides
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Pityriasis Lichenoides
Who may be able to join
- Age ≥ 18 years
- Patients with Pityriasis Lichenoides selected from histological coding OT0431, seen at Henri Mondor and with a diagnosis verified from medical records.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
- Conditions
- Pityriasis Lichenoides
- Keywords
- Pityriasis Lichenoides;, cutaneous lymphoma, lymphoproliferation
- Medical subject headings
- Pityriasis Lichenoides, Lymphoma, T-Cell, Cutaneous
What is being measured
The primary outcome is the main question the study is designed to answer.
To study clinical Aspects of Pityriasis Lichenoides on a large series of adult patients
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.
Measured: It will be measured within 6 months of enrollment
Secondary outcomes (6)
To study histological features of Pityriasis Lichenoides
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.
Measured: It will be measured within 6 months of enrollment
To study molecular features of Pityriasis Lichenoides
number of clone T in the skin and in the blood.
Measured: It will be measured within 6 months of enrollment
To study the treatment during patients' monitoring
number of patients with need of a prolonged treatment
Measured: It will be measured within 6 months of enrollment
To study the duration of outbreak during patients' monitoring
the time to healing
Measured: It will be measured within 6 months of enrollment
To study the relapse during patients' monitoring
the number of relapses
Measured: It will be measured within 6 months of enrollment
To study the number of outbreaks during patients' monitoring
the number of outbreaks
Measured: It will be measured within 6 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pityriasis LichenoidesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saskia ORO, Doctor, Principal investigator, Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920696
- Sponsor's protocol ID
- APHP180538
- Acronym
- EtudePL
- Status last verified
- Feb 2019
- First submitted
- 12 Mar 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Publications
Bowers S, Warshaw EM. Pityriasis lichenoides and its subtypes. J Am Acad Dermatol. 2006 Oct;55(4):557-72; quiz 573-6. doi: 10.1016/j.jaad.2005.07.058.
PubMed 17010734Zang JB, Coates SJ, Huang J, Vonderheid EC, Cohen BA. Pityriasis lichenoides: Long-term follow-up study. Pediatr Dermatol. 2018 Mar;35(2):213-219. doi: 10.1111/pde.13396. Epub 2018 Jan 9.
PubMed 29315771Lalevee S, Ortonne N, Hotz C, Schlemmer F, Beldi-Ferchiou A, Delfau-Larue MH, Wolkenstein P, Chosidow O, Ingen-Housz-Oro S. Febrile ulceronecrotic Mucha Habermann disease mimicking aggressive epidermotropic CD8+ cytotoxic T-cell lymphoma: a diagnostic challenge. Eur J Dermatol. 2018 Dec 1;28(6):834-835. doi: 10.1684/ejd.2018.3410. No abstract available.
PubMed 30325315Geller L, Antonov NK, Lauren CT, Morel KD, Garzon MC. Pityriasis Lichenoides in Childhood: Review of Clinical Presentation and Treatment Options. Pediatr Dermatol. 2015 Sep-Oct;32(5):579-92. doi: 10.1111/pde.12581. Epub 2015 Mar 26.
PubMed 25816855Nair PS. A clinical and histopathological study of pityriasis lichenoides. Indian J Dermatol Venereol Leprol. 2007 Mar-Apr;73(2):100-2. doi: 10.4103/0378-6323.31894.
PubMed 17456915Khachemoune A, Blyumin ML. Pityriasis lichenoides: pathophysiology, classification, and treatment. Am J Clin Dermatol. 2007;8(1):29-36. doi: 10.2165/00128071-200708010-00004.
PubMed 17298104Zaaroura H, Sahar D, Bick T, Bergman R. Relationship Between Pityriasis Lichenoides and Mycosis Fungoides: A Clinicopathological, Immunohistochemical, and Molecular Study. Am J Dermatopathol. 2018 Jun;40(6):409-415. doi: 10.1097/DAD.0000000000001057.
PubMed 29210716Sibbald C, Pope E. Systematic review of cases of cutaneous T-cell lymphoma transformation in pityriasis lichenoides and small plaque parapsoriasis. Br J Dermatol. 2016 Oct;175(4):807-9. doi: 10.1111/bjd.14605. Epub 2016 Jun 20. No abstract available.
PubMed 27031678Vonderheid EC, Kadin ME, Telang GH. Commentary about papular mycosis fungoides, lymphomatoid papulosis and lymphomatoid pityriasis lichenoides: more similarities than differences. J Cutan Pathol. 2016 Apr;43(4):303-12. doi: 10.1111/cup.12653. Epub 2015 Dec 22. No abstract available.
PubMed 26566599
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pityriasis Lichenoides: Anatomo-clinical Aspects and Follow-up Monocentric Retrospective Study
- ClinicalTrials.gov ID
- NCT03920696
- Acronym / sponsor ID
- EtudePL / APHP180538
- Conditions
- Pityriasis Lichenoides
- Keywords
- Pityriasis Lichenoides;, cutaneous lymphoma, lymphoproliferation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Pityriasis Lichenoides
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Patients with Pityriasis Lichenoides selected from histological coding OT0431, seen at Henri Mondor and with a diagnosis verified from medical records.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
To study histological features of Pityriasis Lichenoides
Time frame: 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
To study the treatment during patients' monitoring
Time frame: 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
To study the relapse during patients' monitoring
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Background: PubMed 17010734Bowers S, Warshaw EM. Pityriasis lichenoides and its subtypes. J Am Acad Dermatol. 2006 Oct;55(4):557-72; quiz 573-6. doi: 10.1016/j.jaad.2005.07.058.
- Background: PubMed 29315771Zang JB, Coates SJ, Huang J, Vonderheid EC, Cohen BA. Pityriasis lichenoides: Long-term follow-up study. Pediatr Dermatol. 2018 Mar;35(2):213-219. doi: 10.1111/pde.13396. Epub 2018 Jan 9.
- Background: PubMed 30325315Lalevee S, Ortonne N, Hotz C, Schlemmer F, Beldi-Ferchiou A, Delfau-Larue MH, Wolkenstein P, Chosidow O, Ingen-Housz-Oro S. Febrile ulceronecrotic Mucha Habermann disease mimicking aggressive epidermotropic CD8+ cytotoxic T-cell lymphoma: a diagnostic challenge. Eur J Dermatol. 2018 Dec 1;28(6):834-835. doi: 10.1684/ejd.2018.3410. No abstract available.
- Background: PubMed 25816855Geller L, Antonov NK, Lauren CT, Morel KD, Garzon MC. Pityriasis Lichenoides in Childhood: Review of Clinical Presentation and Treatment Options. Pediatr Dermatol. 2015 Sep-Oct;32(5):579-92. doi: 10.1111/pde.12581. Epub 2015 Mar 26.
- Background: PubMed 17456915Nair PS. A clinical and histopathological study of pityriasis lichenoides. Indian J Dermatol Venereol Leprol. 2007 Mar-Apr;73(2):100-2. doi: 10.4103/0378-6323.31894.
- Background: PubMed 17298104Khachemoune A, Blyumin ML. Pityriasis lichenoides: pathophysiology, classification, and treatment. Am J Clin Dermatol. 2007;8(1):29-36. doi: 10.2165/00128071-200708010-00004.
- Background: PubMed 29210716Zaaroura H, Sahar D, Bick T, Bergman R. Relationship Between Pityriasis Lichenoides and Mycosis Fungoides: A Clinicopathological, Immunohistochemical, and Molecular Study. Am J Dermatopathol. 2018 Jun;40(6):409-415. doi: 10.1097/DAD.0000000000001057.
- Background: PubMed 27031678Sibbald C, Pope E. Systematic review of cases of cutaneous T-cell lymphoma transformation in pityriasis lichenoides and small plaque parapsoriasis. Br J Dermatol. 2016 Oct;175(4):807-9. doi: 10.1111/bjd.14605. Epub 2016 Jun 20. No abstract available.
- Background: PubMed 26566599Vonderheid EC, Kadin ME, Telang GH. Commentary about papular mycosis fungoides, lymphomatoid papulosis and lymphomatoid pityriasis lichenoides: more similarities than differences. J Cutan Pathol. 2016 Apr;43(4):303-12. doi: 10.1111/cup.12653. Epub 2015 Dec 22. No abstract available.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saskia ORO, Doctor principal investigator
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
Questions about this trial
What is this clinical trial studying?
An observational study of Pityriasis Lichenoides, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saskia ORO, Doctor (+33 1 49 81 25 36, saskia.oro@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03920696, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.