Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe and Resistant Alopecia Areata

Alopecia Areata Clinical Trial

— IL2  

Official title:

Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe Alopecia Areata Resistant to Conventional Systemic Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01840046
• Other study ID #: 12-PP-05
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2013
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Interleukin-2
The patient will receive 4 cycles of recombinant interleukin 2 (aldesleukin, Proleukin ®) subcutaneously according to the following dosing schedule: 5 to 7 days (Monday to Friday) in weeks 1, 3, 6 and 9. The dosage is as follows: S1: 1.5 mille-International unit / day (D1 to D5), S3, S6 and S9: 3 mille-International unit /Jour (D1 to D5).

Locations

Country	Name	City	State
France	CHU de Nice - Hôpital Archet	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who obtained an improvement of at least 90% of the score validated severity score in alopecia areata in 2 months.	Number of patients who obtained an improvement of at least 90% of SALT (SALT 90) validated severity score in alopecia areata in 2 months.	2 months
Secondary	Evaluation of the quality of life	Number of patients who obtained an improvement of at least 50% of score (SALT 90) validated severity score in alopecia areata in 2 months.; Assess the partial response rate. Evaluation of the effects of treatment on body hair and nail achieving.; Overall assessment by an independent investigator to regrow after treatment (Physician global assessment): Evaluation of the quality of life before and at the end of treatment. Overall assessment by the patient (patient global assessment) of regrowth. Overall tolerability of treatment. Study population effects of IL2-R on the population of Treg cells in the blood. The effects of IL-2 on the inflammatory infiltrate and the distribution of regulatory T cells in the skin.	2 months