Proactive against reactive therapy for the prevention of lichen sclerosus exacerbation and progression of disease – a pragmatic, parallel group randomised controlled trial with embedded economic evaluation and process evaluation
Vulval lichen sclerosis
In the intervention group participants will be asked to apply potent or superpotent topical corticosteroid (TCS) on two non-consecutive days per week even in the absence of symptoms (proactive treatment). In the comparator group participants will be asked to apply potent or superpotent TCS as required to treat a LS flare (reactive treatment). Eligible patients will be individually allocated in a 1:1 ratio to either proactive or reactive use of TCS. Treatment will be assigned randomly using a minimisation algorithm with a random element, balancing across groups on the recruiting site, age, time since last flare and strength of prescribed TCS. The choice of TCS will be according to the patient’s usual care. PEARLS is a pragmatic trial, and the researchers will test the strategy of proactive vs reactive treatment using the potency of topical corticosteroid recommended by the treating clinician (potent or superpotent). There are several generic names available for these prescribed TCSs and all available brands and forms can be prescribed. The examples of the most commonly prescribed brands/products of the TCS class are: 1. Dermovate ointment - superpotent TCS 2. Elocon® 0.1% w/w ointment - potent TCS The topical dosage of TCSs for both trial groups will be recommended in Fingertip Units (FTU) depending upon the area affected by LS (typically 0.5-1 FTU). FTU is the amount of topical steroid (ointment or cream) that is applied along an adult’s fingertip to the first crease in the finger. One FTU is sufficient to treat an area of skin twice the size of the flat of an adult’s hand with the fingers together (i.e. a ‘handprint’). FTU is also used to treat an area of skin on a child. The treating physician will advise on the dosage for adults or children.
1. Clinical or biopsy confirmed diagnosis of vulval LS 2. Currently controlled disease (asymptomatic with minimal clinical evidence of active disease) at baseline 3. Age ≥5 years 4. Able to give consent/child assent plus parental consent
1. Previous vulval intraepithelial neoplasia (VIN) or vulval squamous cell carcinoma (SCC) 2. Contraindications to topical steroids 3. Concomitant use of other topical anti-inflammatory vulval treatments 4. Using systemic immunosuppressants (for any indication) 5. Using systemic treatment for LS 6. Patients with surgical alteration of vulval skin as part of gender reaffirming surgery, or patients not born with a vulva 7. Pregnant and breastfeeding women