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Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata

Trial Profile

Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 18 Dec 2023

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At a glance

  • Drugs Coacillium (Primary)
  • Indications Alopecia areata
  • Focus Registrational; Therapeutic Use
  • Acronyms RAAINBOW
  • Sponsors Legacy Healthcare
  • Most Recent Events

    • 19 Jun 2023 According to a Legacy Healthcare media release, the company announced that based on the data from this study, Marketing Authorisation Application (MAA) to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for Coacillium for the treatment of moderate and severe alopecia areata in children and adolescents has been validated and is now under CHMP review.
    • 06 Jan 2023 Topline Results published in the Legacy Healthcare Media Release.
    • 06 Jan 2023 Primary endpoint has been met. (Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment.), according to a Legacy Healthcare media release.
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