TREg Activation in the Treatment of the PELADE (Alopecia Areata)

Study Overview
=================
Brief Summary
-----------------
In a prospective pilot study the investigators showed that low doses of IL2 could be beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated. The objective of this study is to compare the long term efficacy of low doses of IL2 versus placebo in a multicenter prospective randomized double blind study.

Official Title
-----------------
TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: IL2
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Of more than 18 years old, Affiliated to the social security system, Clinical diagnosis of alopecia areata, 50 % of the surface of the scalp affected Last flaire started less than one year Alopecia areata resisting to at least 1 systematic treatment including phototherapy (UVB or PUVA), general corticosteroid therapy or methotrexate Signature of the informed consent Exclusion Criteria: Pregnancy or refusal of contraception at the women old enough to procreate, Refusal of contraception at the men Local treatment (dermocorticoïdes, minoxidil) or systematism (oral corticosteroid therapy, méthotrexate or the other immunosuppresseur) since less than 2 less, Evolutionary autoimmune cancer or disease or in forgiveness Excessive grip(taking) of alcohol (upper to 3 glasses of wine a day or one pre-lunch drink a day) Seropositivity VHC, VHB, or HIV Patient presenting a severe renal and/or hepatic insufficiency, Presenting patient one zoned, the chicken pox, the herpes, the tuberculosis, an evolutionary infectious disease, a respiratory failure … Vulnerable person (nobody under guardianship minor(miner), adults, deprived of freedom) IC in the treatment(processing) by IL-2R Presenting a contraindication to ProleukinR

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IL2 - Group A<br>Patient will received IL2 low doses (1.5 to 3MUI/d) - IL2 1.5MUI/d SC from day 1 to day 5 for the first course of treatment IL2 3MUI/d SC from day 1 to day 5 for the 3 following courses | Drug: IL2<br>* IL2 1.5MUI/d SC from day 1 to day 5 for the first course of treatment IL2 3MUI/d SC from day 1 to day 5 for the 3 following courses<br>|
| Placebo Comparator: Placebo - Group B<br>NaCl 9% serum (placebo) NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment | Drug: placebo<br>* NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score Salt | Success defined by a SALT score lower or equal to 25 at the end the study (12 months post-treatment). It will be calculated by 2 physicians blinded to the treatment received on standardized pictures. | Once : at 12 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | The quality of life (QdV) will be estimated with the scale DLQI which is a scale of QdV validated for the dermatological diseases. | at one day, 22 days, 43 days, 64 days, 251 days, 434 days | 
| Adverse Event | The tolerance will be clinically and biologically estimated at each visit. The type and the rank of every AE will be raised. | at one day, 22 days, 43 days, 64 days, 251 days, 434 days | 
| Satisfaction of patient | The satisfaction of the patients will be estimated on an analog visual scale(ladder) going of 0 (not satisfied) to 10 (very satisfied). | at 12 months post-treatment |