Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin

Cairo University (CU)

Status: Unknown

Conditions: Pityriasis Lichenoides

Treatments: Other: nbUVB; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03831269

Kasr Alainy Cairo U

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Azithromycin

Active Comparator group

Description:

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.

Treatment:

Drug: Azithromycin

Nb UVB

Active Comparator group

Description:

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.

Treatment:

Other: nbUVB