NCT03831269

Brief Summary

Primary outcome: The primary outcome at end of study (EOS) is to compare the therapeutic efficacy of Azithromycin in the treatment of pityriasis lichenoides chronica (PLC) with that of a well-documented line of therapy namely narrow band ultra violet B (nbUVB). Secondary outcomes: 1\. To identify the possibility of streptococcal throat infection as a possible underlying etiology in PLC.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

January 25, 2019

Last Update Submit

February 3, 2019

Conditions

Pityriasis Lichenoides

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Azithromycin in treating pityriasis lichenoides chronica

    The clinical improvement of patients with PLC will be evaluated after taking 3 to 6 cycles of azithromycin and will be compared to the clinical outcome of patients that had three sessions of nbUVB for six to eight weeks. Side effects will be documented in each group

    12 months

Study Arms (2)

Azithromycin

ACTIVE COMPARATOR

The dose of azithromycin will be 10mg/kg/day oral suspension for 3 consecutive days for pediatric patients (\<12 years old) and 500mg/day in three consecutive days for adults. The cycle will be repeated every seven days (3 cycles/month) and will be repeated if required according to patient's response up to 6 cycles. Side effects of therapy will be recorded. This protocol is based on previous case reports.

Drug: Azithromycin

Nb UVB

ACTIVE COMPARATOR

Patients recruited for nbUVB phototherapy will have an initial dose of 0.3J-0.5J according to Fitzpatrick's skin type. The dosage will be increased by 0.3J in every other treatment session. The sessions will be given 3 times weekly until improvement is noted or reaching 8 weeks at the EOS. We arrived at this initial dose based on our previous experience with Egyptian patients in Kasr Alainy phototherapy unit in Dermatology Department, Cairo University.

Other: nbUVB

Interventions

AzithromycinDRUG

Patients will be randomly distributed and start taking azithromycin according to the known dose /kg/day for repeated cycles till improvement or reaching the end of study

Azithromycin
nbUVBOTHER

The patients will be randomly distributed to start nbUVB sessions and clinical improvement will be compared to that of Azithromycin

Nb UVB

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with classic papular eruption of PLC (scaly erythematous papules with mica-like scales) with diagnosis documented histopathologically with or without associated hypopigmented lesions
  • Age: \> 6 years
  • Both sexes.

You may not qualify if:

  • Patients presenting with only hypopigmented macules whom their skin biopsy revealed PLC.
  • Patients with hypopigmented lesions that reveal mycosis fungoides pathologically.
  • Patients with PLC associated with classic MF.
  • Patients with known absolute contraindications to NB-UVB.
  • Patients with impaired liver and/or kidney functions.
  • Patients with history of any heart disease.
  • Patients with known hypersensitivity to Azithromycin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy Faculty of Medicine Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Elbendary A, Youssef R, Abdel-Halim MRE, Abdel Halim D, El Sharkawy DA, Alfishawy M, Gad MA, Gad A, Elmasry MF. Role of streptococcal infection in the etiopathogenesis of pityriasis lichenoides chronica and the therapeutic efficacy of azithromycin: a randomized controlled trial. Arch Dermatol Res. 2023 Apr;315(3):521-530. doi: 10.1007/s00403-022-02398-0. Epub 2022 Sep 21.

    PMID: 36129521DERIVED

MeSH Terms

Conditions

Pityriasis Lichenoides

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Lichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesParapsoriasisPityriasis

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Central Study Contacts

Amira Elbendary, MBBCh, MSc

CONTACT

+201555668584aelbendary@kasralainy.edu.eg

Elbendary, MBBCh, MSc

CONTACT

amira.elbendary@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 5, 2019

Study Start

February 1, 2019

Primary Completion

June 1, 2020

Study Completion

August 1, 2020

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Email contact

Locations

EG(1)