TREg Activation in the Treatment of the PELADE (Alopecia Areata)

Alopecia Areata Clinical Trial

— TreatPelade  

Official title:

TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557074
• Other study ID #: 14-API-01
• Status: Completed
• Phase: Phase 3
• Start date: December 15, 2015
• Est. completion date: December 2, 2019

Study information

• Verified date: December 2019
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2, 2019
• Est. primary completion date: February 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Of more than 18 years old,

• Affiliated to the social security system,

• Clinical diagnosis of alopecia areata,

• 50 % of the surface of the scalp affected

• Last flaire started less than one year

• Alopecia areata resisting to at least 1 systematic treatment including phototherapy (UVB or PUVA), general corticosteroid therapy or methotrexate

• Signature of the informed consent

Exclusion Criteria:

• Pregnancy or refusal of contraception at the women old enough to procreate,

• Refusal of contraception at the men

• Local treatment (dermocorticoïdes, minoxidil) or systematism (oral corticosteroid therapy, méthotrexate or the other immunosuppresseur) since less than 2 less,

• Evolutionary autoimmune cancer or disease or in forgiveness

• Excessive grip(taking) of alcohol (upper to 3 glasses of wine a day or one pre-lunch drink a day)

• Seropositivity VHC, VHB, or HIV

• Patient presenting a severe renal and/or hepatic insufficiency,

• Presenting patient one zoned, the chicken pox, the herpes, the tuberculosis, an evolutionary infectious disease, a respiratory failure …

• Vulnerable person (nobody under guardianship minor(miner), adults, deprived of freedom)

• IC in the treatment(processing) by IL-2R

• Presenting a contraindication to ProleukinR

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• IL2
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
NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment

Locations

Country	Name	City	State
France	CHI St Raphael Fréjus - Dermatologie	Fréjus	Paca
France	AP-HM - La timone - Dermatologie	Marseille	Bouche Du Rhône
France	CHU Montpellier - Dermatologie	Montpellier
France	CHU de Nice - dermatologie	Nice
France	CHU de Nimes - Dermatologie	Nîmes	Languedoc-Roussillon
France	AP-HP St Louis - Dermatologie	Paris	Ile De France

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	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
Secondary	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
Secondary	Adverse Event	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
Secondary	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