TREg Activation in the Treatment of the PELADE (Alopecia Areata) (TreatPelade)
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|ClinicalTrials.gov Identifier: NCT02557074|
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : December 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Alopecia Areata||Drug: IL2 Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2|
|Actual Study Start Date :||December 15, 2015|
|Actual Primary Completion Date :||February 2, 2019|
|Actual Study Completion Date :||December 2, 2019|
Experimental: IL2 - Group A
Patient will received IL2 low doses (1.5 to 3MUI/d) -
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
Placebo Comparator: Placebo - Group B
NaCl 9% serum (placebo) NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
- Score Salt [ Time Frame: Once : at 12 months post-treatment ]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.
- Quality of life [ Time Frame: at one day, 22 days, 43 days, 64 days, 251 days, 434 days ]The quality of life (QdV) will be estimated with the scale DLQI which is a scale of QdV validated for the dermatological diseases.
- Adverse Event [ Time Frame: at one day, 22 days, 43 days, 64 days, 251 days, 434 days ]The tolerance will be clinically and biologically estimated at each visit. The type and the rank of every AE will be raised.
- Satisfaction of patient [ Time Frame: at 12 months post-treatment ]The satisfaction of the patients will be estimated on an analog visual scale(ladder) going of 0 (not satisfied) to 10 (very satisfied).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557074
|AP-HM - La timone - Dermatologie|
|Marseille, Bouche Du Rhône, France, 13005|
|AP-HP St Louis - Dermatologie|
|Paris, Ile De France, France, 75000|
|CHU de Nimes - Dermatologie|
|Nîmes, Languedoc-Roussillon, France, 30000|
|CHI St Raphael Fréjus - Dermatologie|
|Fréjus, Paca, France, 83000|
|CHU Montpellier - Dermatologie|
|Montpellier, France, 34000|
|CHU de Nice - dermatologie|
|Nice, France, 06200|
|Principal Investigator:||Passeron Thierry, PUPH||Centre Hospitalier Universitaire de Nice|