Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin

Role of Streptococcal Infection in the Etiopathogenesis of Pityriasis Lichenoides Chronica and the Therapeutic Efficacy of Azithromycin; a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Pityriasis Lichenoides
• Intervention / Treatment: Drug: Azithromycin; Other: nbUVB

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amira Elbendary, MBBCh, MSc; Phone Number: +201555668584; Email: aelbendary@kasralainy.edu.eg
• Study Contact Backup: Name: Elbendary, MBBCh, MSc; Email: amira.elbendary@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alainy Faculty of Medicine Cairo University
    • Contact: Mona Abdel Haleim, MD; Email: abdelhalimmona@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

7. Patients with known hypersensitivity to Azithromycin

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Azithromycin; 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; 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
Active Comparator: Nb UVB; 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; The patients will be randomly distributed to start nbUVB sessions and clinical improvement will be compared to that of Azithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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. 2022 Sep 21. doi: 10.1007/s00403-022-02398-0. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: February 3, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 3, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Parapsoriasis; Streptococcal Infections; Pityriasis; Pityriasis Lichenoides; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: Kasr Alainy Cairo U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Email contact

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No