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

Study Overview
=================
Brief Summary
-----------------
Current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of MF.

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: Baseline biopsy to document the current state of the disease and to assess immunohistochemically the expression of CD3 and Bcl2 by the lymphocytes. Detailed history taking including onset, course, duration of the disease and history of any previous treatments used. Detailed examination of skin lesions and scoring using: Modified Severity of Index Weighted Assessment (mSWAT) Composite Assessment of Index Lesion Severity (CAILS) Pruritus scoring using a visual analog scale from 0-10, where 0=no pruritus and 10=worst imaginable pruritus 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.

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

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: Vibramycin
* Device: Phototherapy


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxycyline<br>Oral Vibramycin antibiotic100 mg capsule every 12 hours for 3 months | Drug: Vibramycin<br>* Antibiotic<br>* Other names: Doxy;Device: Phototherapy<br>* UVA+Psoralen<br>|
| Active Comparator: Phototherapy<br>UVA+ psoralen 3 sessions per week for 3 months | Drug: Vibramycin<br>* Antibiotic<br>* Other names: Doxy;Device: Phototherapy<br>* UVA+Psoralen<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment | 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 | Pathological assessment using immunohistochemistry | 3months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mycosis fungoides, Doxycycline