The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Rouen
• Treatments: Methotrexate; Prednisone

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