Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03831269|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
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).
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
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.
The patients will be randomly distributed to start nbUVB sessions and clinical improvement will be compared to that of Azithromycin
- 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
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
|Contact: Amira Elbendary, MBBCh, MScemail@example.com|
|Contact: Elbendary, MBBCh, MScfirstname.lastname@example.org|
|Kasr Alainy Faculty of Medicine Cairo University|
|Contact: Mona Abdel Haleim, MD email@example.com|