Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin

Pityriasis Lichenoides Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03831269
• Other study ID #: Kasr Alainy Cairo U
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: August 2020

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: Amira Elbendary, MBBCh, MSc
• Phone: +201555668584
• Email: aelbendary[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pityriasis Lichenoides
• Streptococcal Infections

Intervention

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

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

Locations

Country	Name	City	State
Egypt	Kasr Alainy Faculty of Medicine Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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