Monitoring adherence to vulvar lichen sclerosus treatment – a prospective study

Abstract

Background: Vulvar lichen sclerosus treatment consists of topical corticosteroids followed by maintenance therapy. Self-reported adherence to topical corticosteroids in vulvar lichen sclerosus is approximately 66-70.4% and adherence to chronic topical medications is poor.

Objective: To measure treatment adherence for vulvar lichen sclerosus.

Methods: Adults with vulvar lichen sclerosus who were receiving or who were candidates to receive treatment with topical clobetasol propionate 0.05% ointment twice daily received medication tubes equipped with adherence monitors capturing the time and amount of dose dispensed. After 2 months, monitors were returned, and patients were surveyed regarding their adherence.

Results: Ten patients participated for a median (range) of 8.5 (7–11) weeks. Eight (80%) and 7 (70%) caps captured medication timing and dosing events, respectively. Median (interquartile range) adherence was 65% (42–77) and median (interquartile range) medication dispensed per use was 0.15 (0.14 − 0.5) grams. Of the 8 patients using active adherence monitors, 2 did not clinically improve; adherence rates and mean quantity dispensed for these two patients were 31% and 0.13 grams, and 9% and 0.74 grams, respectively.

Conclusion: Poor adherence to both twice daily application and prescribed medication quantity occurred frequently. Factors related to self-reported non-adherence included perceived greater efficacy, inconvenience, and time-constraints. Patient adherence to recommended treatment and clinical outcomes are areas for improvement in patients with vulvar lichen sclerosus.

Keywords:

• Adherence
• lichen sclerosus
• treatment
• vulvar lichen sclerosus

Introduction

Vulvar lichen sclerosus treatment consists of induction with topical corticosteroids followed by lifelong maintenance therapy (1). However, self-reported adherence to topical corticosteroids in vulvar lichen sclerosus is approximately 66-70.4%, and adherence to topical medications in patients with chronic skin disease is poor (2). We assessed adherence prospectively in patients with vulvar lichen sclerosus.

Methods

This study was approved by the Wake Forest Institutional Review Board (IRB00091559). Individuals were eligible for participation if they were greater than 18 years of age and had a clinical diagnosis of vulvar lichen sclerosus. Participants further were required to be receiving or to be candidates to receive treatment with 1 fingertip unit, or 0.5 grams, of topical clobetasol propionate 0.05% ointment twice daily for 2 months. Patients were identified by review of the dermatology clinic schedule and were enrolled between February to March 2023. Patients were counseled that participation in the study would involve using the medication tube with an attached medication monitor and a treatment regimen of twice daily high-potency topical corticosteroids, which is the standard-of-care medication frequency and potency at the vulvar clinic at Wake Forest Department of Dermatology. At the first visit, participants were provided medication tubes equipped with adherence monitors capturing the time and amount of clobetasol dispensed (MyAide^TM by Sensal Health, Chapel Hill, North Carolina). After 2 months, adherence monitors were returned, questionnaires on patient perception of self-adherence were completed, and participants received a $100.00 gift card. Adherence was measured as a percentile with full (100%) adherence determined if two medication doses were dispensed in a 24-h period. The quantity of the medication did not impact the calculated adherence. Clinical improvement was assessed by a board-certified dermatologist (R.P.).

Results

Ten patients with a mean (standard deviation) age of 63 (10) years participated for a median (range) of 8.5 (7–11) weeks. A median (range) of 114 (96–152) medication dosing events were recorded (Table 1). Three (30%) of the 10 caps were damaged. Eight (80%) and 7 (70%) caps captured medication timing and dosing at each event, respectively. Median (interquartile range) adherence was 65% (42–77) and median (interquartile range) medication dispensed per use was 0.15 (0.14 − 0.5) grams. Of the 8 patients using active adherence monitors, 2 did not clinically improve. Adherence rates and mean medication dispensed for these two patients were 31% and 0.13 grams and 9% and 0.74 grams, respectively.

Table 1. Vulvar lichen sclerosus patient adherence to topical corticosteroids.

Patient	Mean weeks of data (weeks)	Number of doses monitored	Adherence rate (%)	Mean weight of medication dispensed per use (grams)	Clinical assessment
1	7	96	88	0.15	Improved
2	8	108	31	0.13	Did not improve
3	8	112	73	0.35	Improved
4	8	105	45	0.56	Improved
5	8	116	96	–	Improved
6	10	140	73	0.09	Improved
7	11	153	9	0.74	Did not improve
8	11	152	57	0.15	Improved

Three (30%) patients self-reported using the medication less frequently than prescribed. Their median (range) adherence was 31% (9–45). Of the 7 (70%) patients who reported using the medication as prescribed, 5 had functioning caps that captured a median (range) adherence of 73% (57–96). The 11-question, open-ended questionnaire distributed to patients assessing adherence was not completed by the majority of patients with the exception of the question regarding what interfered with the patient using the medication as prescribed. Reasons for reduced adherence among the three patients who used the medication less frequently then prescribed included (1) treatment more effective than expected, (2) application was time-consuming, (3) medication stained clothes and surfaces, and (4) medication interfered with daily activities.

Discussion

Untreated vulvar lichen sclerosus risks malignant transformation, with a lifetime risk of 2-6% (3). Both asymptomatic and patients with symptoms of disease are at risk, and lifelong treatment for all patients is advised (1). The self-reported adherence rate of patients with VLS to topical corticosteroids ranges from 66-70.4% (4,5). In our study, the median adherence score was 65%, which was comparable to self-reported adherence from prior studies. In addition, although the adherence score in our study did not incorporate the amount of medication dispensed, the median amount of medication dispensed was 0.15 grams, lower than the 0.5 grams application prescribed. Better adherence was associated with disease improvement; while our sample size is very limited, the number of applications appeared more important than the quantity applied, something we were able to assess because of the capability of the adherence monitors and that can be studied further in the future (Table 1). Factors related to non-adherence included perceived greater efficacy, inconvenience, and time-constraints. These were exacerbated by clothing staining associated with medication use. Both treatment adherence and clinical outcomes are areas for improvement in patients with vulvar lichen sclerosus. Limitations of this study include small sample size, and that the measurement of adherence only incorporated twice daily dispensing of the medication; whether medication was actually applied was not measured. Additionally, the quantity of medication dispensed was not included in the adherence determination. Finally, this was a small, prospective study that was not powered for statistical significance.

Patient consent

Consent for the publication of recognizable patient photographs or other identifiable material was obtained by the authors.

Disclosure statement

Feldman has received research, speaking and/or consulting support from AbbVie, Accordant, Almirall, Alvotech, Amgen, Arcutis, Arena, Argenx, Biocon, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly and Company, Eurofins, Forte, Galderma, Helsinn, Janssen, Leo Pharma, Micreos, Mylan, Novartis, Ono, Ortho Dermatology, Pfizer, Regeneron, Samsung, Sanofi, Sun Pharma, UCB, Verrica, Voluntis, and vTv Therapeutics. He is founder and part owner of Causa Research and holds stock in Sensal Health. Pichardo worked at the advisory board for Novartis. The other authors have no conflicts of interest to disclose.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.