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The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade (MP3)

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ClinicalTrials.gov Identifier: NCT02037191
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
Alopecia areata (AA) is an auto immune disorder. Treatment of severe types remains difficult with a rate of hair regrowth which is lower than 10%. This RCT will assess the safety and efficacy of methotrexate alone or associated with low doses of prednisone versus placebo in the treatment of severe types of AA.

Condition or disease Intervention/treatment Phase
ALOPECIA AREATA Drug: Methotrexate Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RANDOMIZED DOUBLE-BLIND STUDY MULTICENTRIQUE TESTING THE EFFICIENCY OF the METHOTREXATE AT PATIENTS AFFECTED BY GRAVE PELADE (METHOTREXATE VERSUS PLACEBO WITH SECONDARY TREATMENT BY METHOTREXATE and PREDNISONE)
Actual Study Start Date : February 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Placebo Comparator: ARM A : METHOTREXATE

Arm A: methotrexate 20 to 25 mg / week for 6 months. Patients who will experience at least a 25% hair regrowth after the month 5 evaluation will continue methotrexate or placebo from month 6 to the end of the study (month 12).

Non responder patients in both arms A and B will be re-randomized to receive from month 6 to the end of the study (month 12):

  • methotrexate alone or
  • methotrexate associated with prednisone 0.3 mg/Kg/day
Drug: Methotrexate

Non responder patients in arm A will be re-randomized to receive from month 6 to the end of the study (month 12):

methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day

Other Name: Arm A: methotrexate 20 to 25 mg / week for 6 months.

Placebo Comparator: ARM B : PLACEBO

Arm B placebo Patients who will experience at least a 25% hair regrowth after the month 5 evaluation will continue methotrexate or placebo from month 6 to the end of the study (month 12).

Non responder patients in both arms A and B will be re-randomized to receive from month 6 to the end of the study (month 12):

  • methotrexate alone or
  • methotrexate associated with prednisone 0.3 mg/Kg/day
Drug: Placebo

Non responder patients in arm B will be re-randomized to receive from month 6 to the end of the study (month 12):

methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day





Primary Outcome Measures :
  1. OUTCOME MESURE [ Time Frame: MONTH12 ]
    primary outcome Rate of complete or almost complete hair regrowth at the month 12 evaluation in patients treated with methotrexate or placebo who have not been re randomized after the month 5 evaluation and have staid in their initial group of randomization


Secondary Outcome Measures :
  1. SECONDARY OUTCOME MEASURE [ Time Frame: MONTH 6 TO 12 ]

    1 Rate of Global Regrowth Assesment (GRA) at month 6 and 12 .

    • 2 Delay of hair regrowth
    • 3 Rate of relapse
    • 4 Quality of life
    • 5 Safety



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. - age 18 to 70 years old
  2. - informed consent,
  3. - severe type of AA defined as : 3.1 - AA totalis universalis 3.2 - evolving for more than 6 months despite previous treatments including photothérapy (PUVA oru UVB), applications of super potent topical corticosteroid ( clobetasol propionate), applications of minoxidil 5%, or IV pulse corticosteroids 3.3 - DLQI score superior or equal to 10

Exclusion Criteria:

  • Pregnant or breast feeding women
  • VIH + patients
  • active hepatitis B or C
  • treatment with immunosuppressant (ciclosporine, mycophénolate mofetil

    , cyclophosphamide, azathioprine, méthotrexate) within 2 months before inclusion

  • severe cardiac arythma or severe cardiac insufficiency or severe coronary disease
  • liver disorder
  • alcool consumption
  • renal failure
  • Severe diabetes mellitus
  • past history of severe infection
  • past history of néoplasiae ( excluding BCC),
  • Karnofsky index <à 50 %
  • severe lung disorder
  • mental impairment
  • symptomatic osteoporosis
  • blood cytopénia (hémoglobine < 10 g/l ; leucocytes< 3000/mm3, platelets< 100 000/mm3)
  • albuminémia < 25 g/l

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037191


Locations
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France
Head Dermatology Department
Rouen, Haute Normandie, France, 76031
CHU de Rouen - Hôpitaux de Rouen
Rouen, Seine Maritime, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: PASCAL JOLY, PROFESSOR CHU - Hôpitaux de Rouen

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02037191     History of Changes
Other Study ID Numbers: 2011/121/HP
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Keywords provided by University Hospital, Rouen:
ALOPECIA AREATA
TREATMENT METHOTREXATE
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Prednisone
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal