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

August 22, 2018 updated by: Hagar El Sayed, Cairo University

Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides: A Randomized Controlled Trial

Current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of MF.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objectives

Objective is to evaluate the efficacy of doxycycline in treatment of early stages of mycosis fungoides (IA, IB and IIA) and to assess its apoptotic enhancing effect by studying the expression of BCL2 by the T lymphocytes.

Study Design

Randomized controlled trial

Population of study & disease condition

30 patients with early stage mycosis fungoides (Stage Ia,Ib and IIa)

Methodology in details

After signing an informed consent, each participant will be subjected to:

I. Baseline evaluation:

  1. Baseline biopsy to document the current state of the disease and to assess immunohistochemically the expression of CD3 and Bcl2 by the lymphocytes.
  2. Detailed history taking including onset, course, duration of the disease and history of any previous treatments used.

  3. Detailed examination of skin lesions and scoring using:

    • Modified Severity of Index Weighted Assessment (mSWAT)
    • Composite Assessment of Index Lesion Severity (CAILS)
  4. Pruritus scoring using a visual analog scale from 0-10, where 0=no pruritus and 10=worst imaginable pruritus
  5. Photography

II. Treatment and dosing protocol:

Participants will be randomly allocated in either one of the treatment groups:

Group A: Will receive oral doxycycline in a dose of 200 mg daily for three months.

Group B: Will receive PUVA with dosing & increments according to the standard protocols of the Phototherapy Unit, Dermatology Department, Cairo University; 3 sessions per week for 3 months.

III. Timings of follow up visits and clinical assessments done:

Patients will be regularly assessed at weeks 4, 8, and 12. Patients continuing for another three months, as mentioned above, will be assessed at weeks 16, 20 and 24. The following will be done at these follow up visits: mSWAT, CAILS, pruritus scoring and photography. Side effects will be monitored and managed accordingly.

IV. Follow up biopsies:

A repeat biopsy will be taken at initial improvement in CAILS (or at week 12) for immunohistochemical re-assessment of the expression of CD3 and Bcl2 by the lymphocytes.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Recruiting
        • Dermatology departement
        • Contact:
        • Contact:
      • Cairo, Egypt, 11562
        • Recruiting
        • Dermatology department
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doxycyline
Oral Vibramycin antibiotic100 mg capsule every 12 hours for 3 months
Drug: Vibramycin
Antibiotic
Other Names:
  • Doxy
Device: Phototherapy
UVA+Psoralen
Active Comparator: Phototherapy
UVA+ psoralen 3 sessions per week for 3 months
Drug: Vibramycin
Antibiotic
Other Names:
  • Doxy
Device: Phototherapy
UVA+Psoralen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical assessment
Time Frame: 3 months
Clinical assessment of the extent of the lesions in body surface area
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological assessment
Time Frame: 3months
Pathological assessment using immunohistochemistry
3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mona AbdEl Halim, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • doxycycline

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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