Back to resultsPityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin
Primary Purpose
Pityriasis Lichenoides
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Azithromycin
nbUVB
Sponsored by
About this trial
This is an interventional treatment trial for Pityriasis Lichenoides
Eligibility Criteria
Inclusion Criteria:
- Patients with classic papular eruption of PLC (scaly erythematous papules with mica-like scales) with diagnosis documented histopathologically with or without associated hypopigmented lesions
- Age: > 6 years
- Both sexes.
Exclusion Criteria:
- Patients presenting with only hypopigmented macules whom their skin biopsy revealed PLC.
- Patients with hypopigmented lesions that reveal mycosis fungoides pathologically.
- Patients with PLC associated with classic MF.
- Patients with known absolute contraindications to NB-UVB.
- Patients with impaired liver and/or kidney functions.
- Patients with history of any heart disease.
Patients with known hypersensitivity to Azithromycin
-
Sites / Locations
- Kasr Alainy Faculty of Medicine Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Azithromycin
Nb UVB
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03831269
Brief Title
Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin
Official Title
Role of Streptococcal Infection in the Etiopathogenesis of Pityriasis Lichenoides Chronica and the Therapeutic Efficacy of Azithromycin; a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pityriasis Lichenoides
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin
Arm Type
Active Comparator
Arm 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.
Arm Title
Nb UVB
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
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
Other
Intervention Name(s)
nbUVB
Intervention Description
The patients will be randomly distributed to start nbUVB sessions and clinical improvement will be compared to that of Azithromycin
Primary Outcome Measure Information:
Title
Efficacy of Azithromycin in treating pityriasis lichenoides chronica
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with classic papular eruption of PLC (scaly erythematous papules with mica-like scales) with diagnosis documented histopathologically with or without associated hypopigmented lesions
Age: > 6 years
Both sexes.
Exclusion Criteria:
Patients presenting with only hypopigmented macules whom their skin biopsy revealed PLC.
Patients with hypopigmented lesions that reveal mycosis fungoides pathologically.
Patients with PLC associated with classic MF.
Patients with known absolute contraindications to NB-UVB.
Patients with impaired liver and/or kidney functions.
Patients with history of any heart disease.
Patients with known hypersensitivity to Azithromycin
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira Elbendary, MBBCh, MSc
Phone
+201555668584
Email
aelbendary@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Elbendary, MBBCh, MSc
Email
amira.elbendary@yahoo.com
Facility Information:
Facility Name
Kasr Alainy Faculty of Medicine Cairo University
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Abdel Haleim, MD
Email
abdelhalimmona@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Email contact
Citations:
PubMed Identifier
36129521
Citation
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. 2023 Apr;315(3):521-530. doi: 10.1007/s00403-022-02398-0. Epub 2022 Sep 21.
Results Reference
derived
Learn more about this trial
Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin
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