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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03454945
Enrollment
30
Registered
2018-03-06
Start date
2017-03-01
Completion date
2019-04-01
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

Mycosis fungoides, Doxycycline

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: 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.

Interventions

DRUGVibramycin

Antibiotic

DEVICEPhototherapy

UVA+Psoralen

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Clinical assessment3 monthsClinical assessment of the extent of the lesions in body surface area

Secondary

MeasureTime frameDescription
Pathological assessment3monthsPathological assessment using immunohistochemistry

Countries

Egypt

Contacts

Primary ContactHagar El Sayed, Master
hgr_ntr@yahoo.com01061248365
Backup ContactSuzan Shalaby, MD
suzyandnls@gmail.com01224019459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026