Could a Low-Dose immune therapy restore hair in severe alopecia?
NCT ID NCT02557074
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tested whether low doses of interleukin-2 (IL2) can help people with severe alopecia areata, a condition causing patchy or total hair loss. 44 adults with at least 50% scalp hair loss who had not responded to other treatments received either IL2 injections or a placebo. The main goal was to see if hair regrowth reached a certain level (SALT score ≤25) after 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-dose interleukin-2 (IL2)
- What this could lead to
- If it works, this could provide a new treatment option for people with severe alopecia areata who haven't responded to other therapies.
- What could go wrong
- This is a small Phase 3 trial with only 44 participants, so results may not apply to everyone. The treatment involves injections and may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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44 people
The number who actually took part.
- Started
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Dec 2015
- Finished
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Dec 2019
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AP-HM - La timone - Dermatologie
Marseille, Bouche Du Rhône, 13005, France
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AP-HP St Louis - Dermatologie
Paris, Île-de-France Region, 75000, France
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CHI St Raphael Fréjus - Dermatologie
Fréjus, PACA, 83000, France
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CHU Montpellier - Dermatologie
Montpellier, 34000, France
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CHU de Nice - dermatologie
Nice, 06200, France
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CHU de Nimes - Dermatologie
Nîmes, Languedoc-Roussillon, 30000, France
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