Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pityriasis Lichenoides

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

nbUVB

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

nbUVB

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

Intervention Type OTHER

Eligibility Criteria

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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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Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No