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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03920696
Other study ID # APHP180538
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date November 1, 2019

Study information

Verified date February 2019
Source Assistance Publique - Hôpitaux de Paris
Contact Saskia ORO, Doctor
Phone +33 1 49 81 25 36
Email saskia.oro@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

References & Publications (9)

Bowers S, Warshaw EM. Pityriasis lichenoides and its subtypes. J Am Acad Dermatol. 2006 Oct;55(4):557-72; quiz 573-6. Review. — View Citation

Geller 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. Review. — View Citation

Khachemoune A, Blyumin ML. Pityriasis lichenoides: pathophysiology, classification, and treatment. Am J Clin Dermatol. 2007;8(1):29-36. Review. — View Citation

Lalevee 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. — View Citation

Nair PS. A clinical and histopathological study of pityriasis lichenoides. Indian J Dermatol Venereol Leprol. 2007 Mar-Apr;73(2):100-2. — View Citation

Sibbald 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. Review. — View Citation

Vonderheid 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. Review. — View Citation

Zaaroura 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. — View Citation

Zang 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. It will be measured within 6 months of enrollment
Secondary 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. It will be measured within 6 months of enrollment
Secondary To study molecular features of Pityriasis Lichenoides number of clone T in the skin and in the blood. It will be measured within 6 months of enrollment
Secondary To study the treatment during patients' monitoring number of patients with need of a prolonged treatment It will be measured within 6 months of enrollment
Secondary To study the duration of outbreak during patients' monitoring the time to healing It will be measured within 6 months of enrollment
Secondary To study the relapse during patients' monitoring the number of relapses It will be measured within 6 months of enrollment
Secondary To study the number of outbreaks during patients' monitoring the number of outbreaks It will be measured within 6 months of enrollment
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03831269 - Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin N/A