Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03454945
Recruitment Status : Unknown
Verified August 2018 by Hagar El Sayed, Cairo University.
Recruitment status was:  Recruiting
First Posted : March 6, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hagar El Sayed, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of MF.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Vibramycin Device: Phototherapy Phase 3

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides: A Randomized Controlled Trial
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Doxycyline
Oral Vibramycin antibiotic100 mg capsule every 12 hours for 3 months
 Drug: Vibramycin
Antibiotic
Other Name: Doxy

Device: Phototherapy
UVA+Psoralen
Active Comparator: Phototherapy
UVA+ psoralen 3 sessions per week for 3 months
 Drug: Vibramycin
Antibiotic
Other Name: Doxy

Device: Phototherapy
UVA+Psoralen


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Clinical assessment [ Time Frame: 3 months ]
    Clinical assessment of the extent of the lesions in body surface area


Secondary Outcome Measures :
  1. Pathological assessment [ Time Frame: 3months ]
    Pathological assessment using immunohistochemistry


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (above 18) of either sex with established diagnosis of classic MF

Exclusion Criteria:

  • Any variant of MF other than the classic variant.
  • Advanced stages of classic MF: Stage IIb, III or IV.
  • Pregnant and lactating females.
  • Patients with autoimmune diseases e.g. SLE
  • Patients with solid or hematological malignancies e.g. breast cancer, leukemia, etc.
  • Patients with any contraindications for doxycycline (eg: liver disease, kidney disease, photosensitivity, peptic ulcer or patients receiving systemic retinoids).
  • Patients with any contraindication to phototherapy (eg: any other skin cancers or photosensitivity); or to psoralen (eg: liver disease)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03454945


Contacts
Layout table for location contacts
Contact: Hagar El Sayed, Master 01061248365 hgr_ntr@yahoo.com
Contact: Suzan Shalaby, MD 01224019459 suzyandnls@gmail.com

Locations
Layout table for location information
Egypt
Dermatology departement Recruiting
Cairo, Egypt, 11562
Contact: Hagar El Sayed, MD    01051248365    hgr_ntr@yahoo.com   
Contact: Suzan Shalaby, MD    01224019459    suzyandnls@gmail.com   
Dermatology department Recruiting
Cairo, Egypt, 11562
Contact: Hagar El Sayed, Master    01061248365    hgr_ntr@yahoo.com   
Contact: Suzan Shalaby, MD    01224019459    suzyandnls@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: Mona AbdEl Halim, MD Cairo University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Hagar El Sayed, Principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03454945    
Other Study ID Numbers: doxycycline
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hagar El Sayed, Cairo University:
Mycosis fungoides
Doxycycline
Additional relevant MeSH terms:
Layout table for MeSH terms
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents