A Multicenter Trial Evaluating the Safety and Efficacy of a Serum Containing Plant Adaptogens in Patients With Mild-to-Moderate, Persistent Centrofacial Erythema Associated With Rosacea.

BACKGROUND

Persistent facial erythema is one of the most common subtypes of rosacea, often prompting patients to seek treatment. Characterized by multiple factors including adaptive immune and vascular dysregulation, genetics, and environmental influences, skincare measures aimed at reducing erythema and strengthening the skin barrier are fundamental to treatment. Plant adaptogens are rich phytochemicals that promote homeostasis, helping to increase resistance to stress, mitigate inflammation, support the skin barrier, and prevent premature aging. A serum containing plant adaptogens demonstrated significant improvements from baseline in global skin quality in subjects with mild-to-severe facial photodamage over 12 weeks.

OBJECTIVE

We sought to evaluate the safety and efficacy of a serum containing plant adaptogens (MYS) in subjects with mild-to-moderate persistent centrofacial erythema.

METHODS

A multicenter, open-label trial enrolled male or female subjects 30 to 65 years of age with mild (2) to moderate (3) persistent centrofacial erythema based on a Modified Clinical Erythema grading scale (M-CEA; 0=clear to 4=severe). A subset of subjects enrolled was taking oral or topical medications for rosacea (≥6 months) with breakthrough erythema. Subjects with >5 papules or pustules were excluded from participation. The investigators assessed erythema based on the M-CEA scale and global inflammatory lesions utilizing a 5-point grading scale (0=none to 4=severe) at baseline, 2, 4, 8, and 12 weeks. Subjects assessed erythema, dryness/flaking, itching, stinging, and burning using a 5-point grading scale (0=none to 4=severe) at baseline, 2, 4, 8, and 12 weeks. Subjects also completed self-assessment questionnaires. Digital photography and adverse events (AEs) were captured throughout the study. In addition to the study product (MYS [AM/PM]), subjects used a standardized skincare regimen that included a gentle cleanser, moisturizer, and sunscreen.

RESULTS

Fifty-five subjects were enrolled and 51 subjects completed the study: 38 in the Non-Medication Treatment Group (N-MTG) and 13 in the Medication Treatment Group (MTG). Significant mean reductions in the appearance of erythema of -17%, -25%, -32%, and -33% were demonstrated from baseline at Weeks 2, 4, 8, and 12 (all P<0.001), respectively, with each group demonstrating significant reductions over 12 weeks. Subject-assessed erythema demonstrated comparable results for both groups combined, with -22%, -30%, -34%, and -35% significant mean reductions occurring from baseline at Weeks 2, 4, 8, and 12 (all P<0.001). Significant mean reductions also occurred in papules/pustules at Weeks 4 (-29%), 8 (-43%), and 12 (-58%) (n=34; P<0.05). Subjects reported improvements in dryness/flaking, itching, stinging, and burning over the study period. After 12 weeks, subjects (94%) reported that flare-ups were not as intense and their skin looked less blotchy and looked healthier. Subjects (88%) reported feeling less self-conscious about their skin's appearance. One mild, possibly related hypersensitivity reaction on the neck was reported and resolved without sequela. No subject discontinued the study due to an AE.

CONCLUSION

Twice-daily use of a serum comprised of plant adaptogens in subjects with mild-to-moderate persistent centrofacial erythema demonstrated significant reductions in the appearance of erythema from baseline as assessed by investigators and subjects over 12 weeks. Significant reductions from baseline also occurred in papules/pustules. Subjects reported decreases in skin sensitivity and healthier-looking skin.