Alopecia Areata
Conditions
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.
Interventions
DRUGIL2
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
DRUGplacebo
NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score Salt | Once : at 12 months post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | at one day, 22 days, 43 days, 64 days, 251 days, 434 days | The quality of life (QdV) will be estimated with the scale DLQI which is a scale of QdV validated for the dermatological diseases. |
| Adverse Event | at one day, 22 days, 43 days, 64 days, 251 days, 434 days | The tolerance will be clinically and biologically estimated at each visit. The type and the rank of every AE will be raised. |
| Satisfaction of patient | at 12 months post-treatment | The satisfaction of the patients will be estimated on an analog visual scale(ladder) going of 0 (not satisfied) to 10 (very satisfied). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPasseron Thierry, PUPH
Centre Hospitalier Universitaire de Nice
Outcome results
None listed