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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IL2 - Group A | Experimental | Patient will received IL2 low doses (1.5 to 3MUI/d) -
|
|
| Placebo - Group B | Placebo Comparator | NaCl 9% serum (placebo) NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL2 | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score Salt | 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. | Once : at 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | The quality of life (QdV) will be estimated with the scale DLQI which is a scale of QdV validated for the dermatological diseases. | at one day, 22 days, 43 days, 64 days, 251 days, 434 days |
| Adverse Event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Passeron Thierry, PUPH | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HM - La timone - Dermatologie | Marseille | Bouche Du Rhône | 13005 | France | ||
| CHU de Nimes - Dermatologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32941917 | Result | Le Duff F, Bouaziz JD, Fontas E, Ticchioni M, Viguier M, Dereure O, Reygagne P, Montaudie H, Lacour JP, Monestier S, Richard MA, Passeron T. Low-Dose IL-2 for Treating Moderate to Severe Alopecia Areata: A 52-Week Multicenter Prospective Placebo-Controlled Study Assessing its Impact on T Regulatory Cell and NK Cell Populations. J Invest Dermatol. 2021 Apr;141(4):933-936.e6. doi: 10.1016/j.jid.2020.08.015. Epub 2020 Sep 14. No abstract available. |
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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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| placebo | Drug | NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment |
|
The tolerance will be clinically and biologically estimated at each visit. The type and the rank of every AE will be raised.
| at one day, 22 days, 43 days, 64 days, 251 days, 434 days |
| Satisfaction of patient | The satisfaction of the patients will be estimated on an analog visual scale(ladder) going of 0 (not satisfied) to 10 (very satisfied). | at 12 months post-treatment |
| Nîmes |
| Languedoc-Roussillon |
| 30000 |
| France |
| CHI St Raphael Fréjus - Dermatologie | Fréjus | PACA | 83000 | France |
| CHU Montpellier - Dermatologie | Montpellier | 34000 | France |
| CHU de Nice - dermatologie | Nice | 06200 | France |
| AP-HP St Louis - Dermatologie | Paris | Île-de-France Region | 75000 | France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |