POWER: Topical oestrogen in people with vulval lichen sclerosus

• Research type

  Research Study

• Full title

  POWER study: toPical Oestrogen in patients With vulval lichen sclERosus. A mixed methods study to inform future trial design.

• IRAS ID

  359594

• Contact name

  Jaskiran Azad

• Contact email

  j.azad@nhs.net

• Sponsor organisation

  Tees Valley Research Alliance

• Duration of Study in the UK

  0 years, 9 months, 1 days

• Research summary

  Background:
  Lichen sclerosus is the most common inflammatory skin condition affecting the genital area. The standard treatment for vulval lichen sclerosus (VLS) is topical steroids. There is need for other topical treatments as demonstrated through the James Lind Alliance Lichen Sclerosus Priority Setting Partnership. Postmenopausal women make up the largest group of diagnosed VLS and furthermore we observe symptomatic peaks occuring at time of menstrual changes suggesting hormones may have a role. Topical oestrogen is widely prescribed for genito-urinary symptoms of menopause. Anecdotally, many people with VLS report a benefit from topical oestrogen, regardless of their menopausal status although this has not been studied. There is need for a well designed randomised controlled trial to assess this question definitively and to provide an evidence base for clinical guidelines.

  Objectives
  The objective of this study is to inform the design of a future randomised controlled trial assessing the potential benefit of topical oestrogen in VLS.

  Population
  People with VLS
  Healthcare professionals (HCPs) who routinely care for people with VLS

  Design and setting
  Mixed methods study undertaken across UK

  Methods
  National online surveys for people with VLS
  National online surveys for HCPs
  Series online focus groups for people with VLS and HCPs

  Expected outputs
  To identify:
  How common it is for people with VLS to be prescribed topical oestrogen
  Primary and secondary outcomes for future randomised controlled trial (RCT)
  Barriers and facilitators to recruitment and retention
  Willingness of HCPs to recruit
  Appropriate eligibility criteria
  Design of future RCT

  Timeline
  12months

• REC name

  West of Scotland REC 5

• REC reference

  25/WS/0193

• Date of REC Opinion

  10 Dec 2025

• REC opinion

  Favourable Opinion