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ALOPECIA AREATA | The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade

ALOPECIA AREATA research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

ALOPECIA AREATA

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MethotrexateNon 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

Drug:PlaceboNon 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ARM A : METHOTREXATEArm 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

ARM B : PLACEBOArm 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

Study Status

Recruiting

Start Date: February 2014

Completed Date: December 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: OUTCOME MESURE

Secondary Outcome: SECONDARY OUTCOME MEASURE

Study sponsors, principal investigator, and references

Principal Investigator: PASCAL JOLY, PROFESSOR

Lead Sponsor: University Hospital, Rouen

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02037191

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