Clinical trial NCT02557074: TREg Activation in the Treatment of the PELADE (Alopecia Areata)
Official title: TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia Areata
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Score Salt
timeFrame: Once : at 12 months post-treatment
Secondary outcomes:
measure: Quality of life
timeFrame: at one day, 22 days, 43 days, 64 days, 251 days, 434 days
measure: Adverse Event
timeFrame: at one day, 22 days, 43 days, 64 days, 251 days, 434 days
measure: Satisfaction of patient
timeFrame: at 12 months post-treatment
Other outcomes:
Locations:
city: Marseille
country: France
facility: AP-HM - La timone - Dermatologie
state: Bouche Du Rhône
city: Paris
country: France
facility: AP-HP St Louis - Dermatologie
state: Ile De France
city: Nîmes
country: France
facility: CHU de Nimes - Dermatologie
state: Languedoc-Roussillon
city: Fréjus
country: France
facility: CHI St Raphael Fréjus - Dermatologie
state: Paca
city: Montpellier
country: France
facility: CHU Montpellier - Dermatologie
city: Nice
country: France
facility: CHU de Nice - dermatologie
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Passeron Thierry, PUPH
role: PRINCIPAL_INVESTIGATOR
References: