BACKGROUND: The management of papulopustular rosacea presents a significant clinical challenge. Anti-inflammatory and vasoconstrictive treatments are ineffective in the rapid amelioration of the dryness, burning, and itching caused by skin barrier damage in patients with papulopustular rosacea.

AIMS: To assess the efficacy and safety of the topical application of compound heparin sodium allantoin gel to treat rosacea.

METHODS: Eighty-two patients participated in this randomized, prospective, single-center, and controlled trial. The Clinician Erythema Assessment score, Investigator Global Assessment score, transepidermal water loss, and skin hydration were evaluated at 0, 2, 4, 8, and 12 weeks. Rosacea-specific quality of life score, itching, dryness, burning, Global Aesthetic Improvement Scale, and Patient Self-Assessment grades were also assessed.

RESULTS: Compared with the traditional therapy group, the 8-week and 12-week topical application of compound heparin sodium allantoin gel to treat rosacea significantly decreased Clinician Erythema Assessment/Investigator Global Assessment grades, burning and itching grades, and rosacea-specific quality of life scores. Compound heparin sodium allantoin gel significantly improved the skin barrier with hydration and significantly decreased trans-epidermal water loss. For patients with Demodex infestation, externally applied compound heparin sodium allantoin gel was associated with better rosacea treatment outcomes and improved skin barrier function than externally applied hyaluronic acid. This may be attributable to the inhibition of abnormal demodex, improved skin barrier, and repair of minor skin wounds.

CONCLUSIONS: Compound heparin sodium allantoin gel effectively improved facial erythema, alleviated ithching and burning sensations, and improved patients' quality of life.

TRAIL REGISTRATION: ClinicalTrials.gov identifier: ChiCTR2400087948.