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Completed

NCT Number: NCT07606820

Real-World Study of Crisugabalin(HSK16149) for the Treatment of Rosacea

A Real-World Study of Crisugabalin(HSK16149) for the Treatment of Rosacea

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of rosacea according to the criteria established by the ROSacea COnsensus (ROSCO) 2019 guidelines.
  • Presence of obvious facial erythema accompanied by significant burning and tingling sensations, with subjective symptoms (e.g., burning and tingling) being more severe than the observable clinical signs.
  • Refractory facial erythema despite conventional treatment, including antibiotics (metronidazole, doxycycline, and minocycline), oral isotretinoin, and oral beta-blockers.

Exclusion criteria

  • Facial inflammatory dermatoses such as acne, contact dermatitis, seborrheic dermatitis, or other facial skin diseases.
  • Pregnancy or lactation.
  • Hepatic or renal insufficiency.
  • Ongoing treatment with long-term topical glucocorticoids or retinoids.

Treatment and study plan

Crisugabalin(HSK16149)20mg BID

Drug

different dose

Crisugabalin(HSK16149) 20mg qd

Drug

different dose

Primary outcomes

  1. CEA

    Time frame: baseline and 4w after treatment

    Rosacea Facial Erythema Score

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 26, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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