Clinical trial NCT01840046: Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe and Resistant Alopecia Areata
Official title: Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe Alopecia Areata Resistant to Conventional Systemic Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Alopecia Areata
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Alopecia areata is an autoimmune disease associated with infiltration of cluster of differentiation 4(CD4 +) and cluster of differentiation 8 (CD8) + cells around the hair follicles. One of the therapeutic approaches of inflammatory diseases such as alopecia areata is the induction of tolerance. This tolerance induction can be obtained by stimulating regulatory T cells (Treg). The low-dose interleukin-2 plays a central role in the development, expansion, regulation and survival of regulatory T cells CD4 + cluster of differentiation 25 (CD25) + forkhead box protein 3 (FoxP3). Recently, recombinant interleukin 2 (IL2-R) with low dose showed very promising results in two inflammatory disease (GVHD vasculitis and cryoglobulinemia secondary to hepatitis C): clinical efficacy, increased population Treg in the blood and an excellent safety profile. We hypothesized that administration of IL2-R in patients with severe alopecia areata might allow regrowth via activation of Treg and thus induce regrowth of the air.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years, 60 ≤ years.
* Male or female
* Clinical diagnosis of alopecia areata,
* Severe alopecia areata (\> 50% of the surface of the scalp reached)
* Alopecia areata resistant to at least one systemic therapy: phototherapy (UVB or PUVA), methotrexate or corticosteroids
* Signature of the informed consent and authorization of the right image
* Effective contraception will be maintained for the duration of the study.
* Affiliation to the Social Security

Exclusion Criteria:

* Pregnancy or refusal of contraception in women of childbearing age,
* Refusal of contraception for men
* Local treatment (corticosteroids, minoxidil) or systemic (oral corticosteroids, methotrexate or other immunosuppressive agents) for less than 2 months,
* Cancer or autoimmune disease or in remission evolutionary
* Excessive alcohol intake (more than 3 glasses of wine a day or a drink per day)
* HIV, hepatitis C virus, hepatitis B virus
* Patient with renal and / or hepatic impairment,
* Patient with shingles, chickenpox, herpes, tuberculosis, an infectious disease scalable, respiratory failure ...
* Vulnerable person (anyone younger, adults under guardianship, deprived of liberty)
* Indication against treatment with IL2-R
* Presenting an indication against the Proleukin

Primary outcomes:
measure: Number of patients who obtained an improvement of at least 90% of the score validated severity score in alopecia areata in 2 months.
timeFrame: 2 months
Secondary outcomes:
measure: Evaluation of the quality of life
timeFrame: 2 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital Archet
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice - Hôpital de l'Archet - Dermatology
name: PASSERON Thierry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castela E, Le Duff F, Butori C, Ticchioni M, Hofman P, Bahadoran P, Lacour JP, Passeron T. Effects of low-dose recombinant interleukin 2 to promote T-regulatory cells in alopecia areata. JAMA Dermatol. 2014 Jul;150(7):748-51. doi: 10.1001/jamadermatol.2014.504.