Skip to content

Core outcomes for research in lichen sclerosus (CORALS)


Genital lichen sclerosus


Genital Lichen sclerosus (LS) is an inflammatory skin condition that affects men, women and children. It is thought to affect around 1% of women; the prevalence in men and children is unknown. In women, 3-5% go on to develop vulval malignancy and treatment may reduce this risk. In addition, LS impacts upon psychosocial and sexual well-being. Published interventional randomised controlled trials are of poor methodological quality and difficult to combine in meta-analyses. This is partly due to lack of validated and agreed upon outcome measures to assess treatment response.

Scope of the intended COS

  • Study types: interventional clinical trials
  • Region: global


The project will be led by a multidisciplinary Steering Group including patient representation. A three-stage process will be used to establish domains to be used for the future core outcome set: 1) Identification of potential domains that could be measured: domains will be harvested through up to date systematic reviews of quantitative and qualitative genital LS studies; survey responses collected by the LS Priority Setting Partnership and discussion groups with patients. 2) Provisional agreement of the most important domains: international Electronic-Delphi consensus study involving different stakeholder groups; 3) Final agreement of domains: Consensus meeting involving different stakeholder groups to be held.

Involvement of stakeholders

Stakeholders for CORALS include a number of groups who are involved in the management of patients with LS, who have LS themselves, who plan/publish/research studies for interventions in LS or who develop treatments for LS. The following are considered stakeholders to be involved as participants in the study to agree core domains:

Dermatologists, Gynaecologists, Histopathologists, Specialist Nurses, Urologists, Oncologists, Sexual Health Medicine practitioners, Patients, Journal Editors, Regulatory bodies, Industry Representatives, Clinical trialists, Systematic reviewers

Current status

Development of domains, e-Delphi survey planned to launch end of 2020


This study has been funded by the UK Dermatology Clinical Trials Network (UK DCTN) through the 2018 Themed call Research Award.

Involved Countries

Canada, United States, Germany, Italy, Denmark, United Kingdom

Date of updates



  • Dr Rosalind Simpson

Project team members

  • H.B. (Female patient)
  • Suzanne von Seitzberg (Lead of Danish patient support group)
  • R. P. (Male patient representative)
  • Gudula Kirtschig (Dermatologist)
  • Amanda Selk (Gynaecologist)
  • David Foster (Gynaecologist)
  • Kim Thomas (Methodologist, non-clinical)
  • Ione Bissonnette (Registered Nurse, CNM, MSN)
  • Gitte Vittrup – (Nurse and Sexologist)
  • Martin Promm (Paediatric Urologist)
  • Stefano Lauretti (Urologist)
  • Angelo Augenti (Urologist)

Responsible member of Methods group (as assigned by CS-COUSIN)

  • Dr. Jan Kottner