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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interleukin 2 | Experimental | 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 (MIU) / day D1 to D5, S3, S6 and S9: 3 mille-International unit /Jour D1 to D5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interleukin-2 | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PASSERON Thierry, PhD | CHU de Nice - Hôpital de l'Archet - Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice - Hôpital Archet | Nice | Alpes-Maritimes | 06001 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24872229 | Derived | 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. |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| 2 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |