Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides
NCT ID: NCT03454945
Last Updated: 2018-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2017-03-01
2019-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Doxycyline
Oral Vibramycin antibiotic100 mg capsule every 12 hours for 3 months
Vibramycin
Antibiotic
Phototherapy
UVA+Psoralen
Phototherapy
UVA+ psoralen 3 sessions per week for 3 months
Vibramycin
Antibiotic
Phototherapy
UVA+Psoralen
Interventions
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Vibramycin
Antibiotic
Phototherapy
UVA+Psoralen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Hagar El Sayed
Principle investigator
Principal Investigators
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Mona AbdEl Halim, MD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Dermatology departement
Cairo, , Egypt
Dermatology department
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
El Sayed H, Shalaby S, Abdel-Halim MRE, Aboelfadl DM, Samir N. Efficacy of doxycycline in the treatment of early stages of mycosis fungoides: a randomized controlled trial. J Dermatolog Treat. 2021 Jun;32(4):424-431. doi: 10.1080/09546634.2019.1667474. Epub 2019 Sep 20.
Other Identifiers
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doxycycline
Identifier Type: -
Identifier Source: org_study_id
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