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

Last updated: December 3, 2019
Sponsor: Centre Hospitalier Universitaire de Nice
Overall Status: Completed

Phase

3

Condition

Alopecia

Hair Loss

Treatment

N/A

Clinical Study ID

NCT02557074
14-API-01
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 corticosteroidtherapy, 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-lunchdrink 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, anevolutionary infectious disease, a respiratory failure …

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

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

  • Presenting a contraindication to ProleukinR

Study Design

Total Participants: 44
Study Start date:
December 15, 2015
Estimated Completion Date:
December 02, 2019

Connect with a study center

  • AP-HM - La timone - Dermatologie

    Marseille, Bouche Du Rhône 13005
    France

    Site Not Available

  • AP-HP St Louis - Dermatologie

    Paris, Ile De France 75000
    France

    Site Not Available

  • CHU de Nimes - Dermatologie

    Nîmes, Languedoc-Roussillon 30000
    France

    Site Not Available

  • CHI St Raphael Fréjus - Dermatologie

    Fréjus, Paca 83000
    France

    Site Not Available

  • CHU Montpellier - Dermatologie

    Montpellier, 34000
    France

    Site Not Available

  • CHU de Nice - dermatologie

    Nice, 06200
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.