Controlled Release Formulation of STS01 to treat Alopecia Areata

• Research type

  Research Study

• Full title

  A Double-Blind, Multi-site, Placebo Controlled, Parallel Group Design to Assess the Efficacy, Safety and Dose Response Characterisation of a Controlled Release Formulation of STS01 (Dithranol/ProSilic) for the Treatment of Mild-Moderate Patchy Alopecia Areata (AA).

• IRAS ID

  304441

• Contact name

  David Fleet

• Contact email

  davidfleet@manentia.co.uk

• Sponsor organisation

  Soterios Ltd

• Eudract number

  2021-004145-20

• Duration of Study in the UK

  1 years, 3 months, 31 days

• Research summary

  This is a Phase II, dose response investigation to assess the efficacy and safety of a range of doses of a controlled release formulation of dithranol for the treatment of mild - moderate patchy alopecia areata (AA).

  The objectives of the study are as follows:

  •To investigate the efficacy of individual treatment doses using both clinical measures and surrogate markers of response.
  •To investigate the safety profile of each treatment dose.
  •To investigate the dose response profile across the range of treatment doses selected.
  •To select a suitable dose concentration of the formulation to take forward to a confirmatory Phase III clinical evaluation.

  The IMP is a reformulation of dithranol with ProSilic® (a fully biodegradable hybrid of porous elemental silicon (Si14), lipids and amino acids) which will enable control of drug release, consequently reducing the oxidative reactivity but improving anti-inflammatory potential whilst still allowing permeation into the skin epidermis and the hair follicle bulb target.

  Eligible subjects will be male or female aged 18 years or older with mild to moderate Alopecia areata (AA) which has been present for at least 6 months prior to screening (but not more than 2 years) and not treated for at least one month.

  Standard clinical diagnostic examination will identify AA caused hair loss, severity (mild to moderate) and type of hair loss (solitary round or oval patches (monolocularis), numerous (multilocularis) or conjoined (reticular) patches).

  Treatment and clinical assessment for a period of 6 months with a follow up for assessment of safety and relapse after a further 2 month period.

• REC name

  London - South East Research Ethics Committee

• REC reference

  21/LO/0851

• Date of REC Opinion

  10 Dec 2021

• REC opinion

  Further Information Favourable Opinion