Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin

Not Applicable

• Conditions: Pityriasis Lichenoides
• Interventions: Other: nbUVB; Drug: Azithromycin

• Registration Number: NCT03831269
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-25
• Status Verified: 2019-02
• Study Start: 2019-02
• Study First Submitted QC: 2019-02-03
• Last Update Submitted: 2019-02-03
• Study First Posted: 2019-02-05
• Last Update Posted: 2019-02-05
• Primary Completion: 2020-06
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nb UVB	nbUVB	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.
Azithromycin	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of Azithromycin in treating pityriasis lichenoides chronica	12 months	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

Trial Locations

Locations (1)

Kasr Alainy Faculty of Medicine Cairo University; 🇪🇬 Cairo, Egypt