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

March 20, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34000
        • CHU Montpellier - Dermatologie
      • Nice, France, 06200
        • CHU de Nice - dermatologie
    • Bouche Du Rhône
      • Marseille, Bouche Du Rhône, France, 13005
        • AP-HM - La timone - Dermatologie
    • Languedoc-Roussillon
      • Nîmes, Languedoc-Roussillon, France, 30000
        • CHU de Nimes - Dermatologie
    • PACA
      • Fréjus, PACA, France, 83000
        • CHI St Raphael Fréjus - Dermatologie
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75000
        • AP-HP St Louis - Dermatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Comparator: Placebo - Group B
NaCl 9% serum (placebo) NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
Drug: placebo
NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Once : at 12 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at one day, 22 days, 43 days, 64 days, 251 days, 434 days
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.
at one day, 22 days, 43 days, 64 days, 251 days, 434 days
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).
at 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Passeron Thierry, PUPH, Centre Hospitalier Universitaire de Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2015

Primary Completion (Actual)

February 2, 2019

Study Completion (Actual)

December 2, 2019

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimated)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-API-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alopecia Areata

Clinical Trials on IL2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe