Establishing a Core Domain Set for Rosacea Clinical Trials

Rosacea presents with a variety of symptoms, including persistent facial redness, papules, pustules, and ocular discomfort. It affects approximately 5.5% of the global adult population, with a notable prevalence in individuals with darker skin tones. Despite various available treatments, the inconsistent reporting of outcomes in clinical trials has impeded accurate data pooling and meta-analyses. To enhance the comparability and quality of research studies, a recent consensus statement established key domains for a core outcome set for rosacea, with the aim that it be globally relevant, applicable to all demographic groups, and able to be used in both clinical trials and practice. 

Methods 

A systematic literature review targeted randomized and controlled clinical trials published between 2010 and 2020, extracting 192 discrete outcomes. These were refined to 50 unique outcomes through a Delphi process involving 88 panelists, including 63 physicians from 17 countries and 25 patients with rosacea. The outcomes were rated on a 9-point Likert scale, with additional outcomes added in subsequent rounds based on feedback. Outcomes deemed critical by at least 85% of participants were included in the final domain set, which followed guidance provided by the Core Outcome Measures in Effectiveness Trials Initiative and Cochrane Skin Core Outcome Set Initiative and adhered to the Core Outcome Set–Standards for Reporting. 

Findings 

The consensus process identified a core set of 8 domains: 

1. Ocular signs and symptoms. This domain encompasses ocular manifestations, such as blepharitis and corneal involvement, which can lead to significant complications, including vision loss. Including these signs ensures that ocular rosacea, although less common, is adequately monitored and treated. 

2. Skin signs of disease. This domain includes nontransient erythema, telangiectasia, papules, pustules, edema, and phymatous changes. These signs are critical for diagnosing and tracking the progression of rosacea, ensuring that all major physical manifestations are considered. 

3. Skin symptoms. This domain addresses symptoms such as flushing, warmth, and burning or stinging sensations. Including these subjective experiences ensures that the patient’s perspective on disease severity and discomfort is captured. 

4. Overall severity. Both patients and physicians assess the overall severity of rosacea, providing a comprehensive view of the disease’s impact. This dual assessment helps bridge the gap between clinical observations and patient experiences. 

5. Patient satisfaction. This domain evaluates how satisfied patients are with their treatment, an essential aspect of chronic disease management that can influence treatment adherence and overall outcomes. 

6. Quality of life. Given that rosacea can significantly impact a patient's quality of life, this domain is crucial for understanding the broader effects of the disease and the benefits of treatments beyond physical symptoms. 

7. Degree of improvement. This domain measures the extent of improvement following treatment, helping to determine the efficacy of interventions at their peak effect. 

8. Treatment-related adverse events. Monitoring adverse events, including their presence and severity, ensures that treatments are not only effective but also safe for patients. 

These domains encompass the most critical aspects of rosacea, addressing both clinical and patient-reported outcomes. The inclusion of ocular signs and symptoms reflects the potential severity of untreated ocular rosacea, which can lead to vision loss. Skin signs and symptoms are also prioritized to capture the diverse manifestations of rosacea. 

Discussion 

The core domain set aims to standardize outcome measurements, enabling better data comparability across studies. The adoption of this core domain set by researchers and clinicians is expected to streamline the reporting of rosacea outcomes, making it easier to compare and combine data from different studies. This standardization will enhance the reliability of meta-analyses and systematic reviews, ultimately contributing to a more robust evidence base for rosacea treatments. 

One of the significant strengths of this core domain set is its inclusivity. Involving a diverse group of stakeholders, including international experts and patients, ensures that the selected domains are relevant across different populations and settings. This inclusivity helps address previous gaps in research, particularly regarding the underrepresentation of patients with darker skin tones in rosacea studies. 

In clinical practice, the core domain set can be integrated into electronic health record systems, providing a standardized framework for assessing and managing rosacea. This integration will facilitate consistent monitoring of disease progression and treatment outcomes, ultimately improving patient care. In addition, the inclusion of patient-reported outcomes, such as quality of life and satisfaction with treatment, can capture the patient’s perspective to help clinicians better understand the full impact of rosacea and tailor treatments to meet individual needs. 

Conclusion 

The establishment of this core domain set marks a significant step toward standardizing outcome measures in rosacea research. By implementing these key domains in future clinical trials and practice, researchers and clinicians can improve the quality and comparability of rosacea studies, ultimately enhancing patient care. 

Reference 

Dirr MA, Ahmed A, Schlessinger DI, et al. Rosacea core domain set for clinical trials and practice: a consensus statement. JAMA Dermatol. 2024;160(6):658-666. doi:10.1001/jamadermatol.2024.0636