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NCT Number: NCT02557074

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

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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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AP-HM - La timone - Dermatologie, Marseille, Bouche Du Rhône, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: TreatPelade

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2015
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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