Systemic therapy for vulval Erosive Lichen Planus (the ‘hELP’ trial): study protocol for a randomised controlled trial

Table 1 Summary of the Systemic therapy for vulval Erosive Lichen Planus (‘hELP’) trial assessments to be made at study visits

Assessment	0 months			1 month	3 months	6 months	12 months^g
Assessment	Screening/Eligibility	Baseline/Randomisation	Start of treatment	1 month	3 months	6 months	12 months^g
Informed consent		✓
Eligibility checks	✓
Medical history	✓	✓					✓
Demographics		✓
Randomisation		✓
Standard safety monitoring^a		✓		✓	✓	✓
Pregnancy test^b			✓	✓	✓	✓	Check status
Prescription given^c			✓	✓	✓	✓
Treatment log^d			✓	✓	✓	✓
Digital photographs^e		✓				✓
Pain/Soreness score^f		✓			✓	✓
PGA^f		✓			✓	✓	✓
Investigator assessment of vulva		✓			✓	✓
Investigator assessment of other affected sites		✓			✓	✓
HADS score^f		✓				✓
Assessment of sexual function^f		✓				✓
Skindex-29^f		✓				✓
SF36^f		✓				✓
Patient diary^f		✓		✓	✓	✓
Adverse events				✓	✓	✓

HADS Hospital Anxiety and Depression Scale, PGA Patient Global Assessment, SF36 ‘Short Form 36’
^aAs per national guidance
^bFor women of childbearing potential who are sexually active
^cDoses titrated according to ‘hELP’ study protocol
^dRecord any prescriptions given during follow-up visit
^ePhotographs ideally to be taken by medical photography (photographs at baseline and 6 months must be by same mode), analysis by blinded assessor at coordinating centre
^fAssessment completed by the participant
^gAssessment to be carried out by telephone, letter or Email

ISSN: 1745-6215