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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557074
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief 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.


Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: IL2 Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
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
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Passeron Thierry, PUPH Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02557074    
Other Study ID Numbers: 14-API-01
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical