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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02557074 |
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Date of registration:
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11/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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TREg Activation in the Treatment of the PELADE (Alopecia Areata)
TreatPelade |
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Scientific title:
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TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2 |
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Date of first enrolment:
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December 15, 2015 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02557074 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Passeron Thierry, PUPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire de Nice |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alopecia Areata
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Intervention(s)
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Drug: IL2
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Drug: placebo
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Primary Outcome(s)
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Score Salt
[Time Frame: Once : at 12 months post-treatment]
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Secondary Outcome(s)
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Quality of life
[Time Frame: at one day, 22 days, 43 days, 64 days, 251 days, 434 days]
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Satisfaction of patient
[Time Frame: at 12 months post-treatment]
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Adverse Event
[Time Frame: at one day, 22 days, 43 days, 64 days, 251 days, 434 days]
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Secondary ID(s)
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14-API-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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