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Trial record 2 of 66 for:    Recruiting, Not yet recruiting, Available Studies | "Streptococcal Infections"

Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin

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ClinicalTrials.gov Identifier: NCT03831269
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Amira Elbendary, 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.


Condition or disease Intervention/treatment Phase
Pityriasis Lichenoides Drug: Azithromycin Other: nbUVB Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Role of Streptococcal Infection in the Etiopathogenesis of Pityriasis Lichenoides Chronica and the Therapeutic Efficacy of Azithromycin; a Randomized Controlled Trial
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Active Comparator: 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.
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

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




Primary Outcome Measures :
  1. Efficacy of Azithromycin in treating pityriasis lichenoides chronica [ Time Frame: 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



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831269


Contacts
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Contact: Amira Elbendary, MBBCh, MSc +201555668584 aelbendary@kasralainy.edu.eg
Contact: Elbendary, MBBCh, MSc amira.elbendary@yahoo.com

Locations
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Egypt
Kasr Alainy Faculty of Medicine Cairo University Recruiting
Cairo, Egypt
Contact: Mona Abdel Haleim, MD       abdelhalimmona@gmail.com   
Sponsors and Collaborators
Cairo University

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Responsible Party: Amira Elbendary, Teaching assistant, Cairo University
ClinicalTrials.gov Identifier: NCT03831269     History of Changes
Other Study ID Numbers: Kasr Alainy Cairo U
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Email contact

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Streptococcal Infections
Pityriasis
Pityriasis Lichenoides
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Papulosquamous
Skin Diseases
Lichenoid Eruptions
Parapsoriasis