Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides
1 other identifier
interventional
30
1 country
2
Brief Summary
Current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of MF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 lymphoma
Started Mar 2017
Shorter than P25 for phase_3 lymphoma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
March 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedAugust 23, 2018
August 1, 2018
2.1 years
September 5, 2017
August 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical assessment
Clinical assessment of the extent of the lesions in body surface area
3 months
Secondary Outcomes (1)
Pathological assessment
3months
Study Arms (2)
Doxycyline
EXPERIMENTALOral Vibramycin antibiotic100 mg capsule every 12 hours for 3 months
Phototherapy
ACTIVE COMPARATORUVA+ psoralen 3 sessions per week for 3 months
Interventions
Eligibility Criteria
You may qualify if:
- Adults (above 18) of either sex with established diagnosis of classic MF
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
Dermatology departement
Cairo, 11562, Egypt
Dermatology department
Cairo, 11562, Egypt
Related Publications (2)
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.
PMID: 32632956DERIVEDEl 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.
PMID: 31526286DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mona AbdEl Halim, MD
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
September 5, 2017
First Posted
March 6, 2018
Study Start
March 1, 2017
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
August 23, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share