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

May 29, 2026 updated by: The First Affiliated Hospital with Nanjing Medical University
A Real-World Study of Cligabalin(HSK16149) for the Treatment of Neurogenic Rosacea

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

nclusion Criteria

Participants were eligible for inclusion if they met all of the following criteria:

Diagnosis of rosacea according to the criteria established by the ROSacea COnsensus (ROSCO) 2017 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

Patients were excluded if they had:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cligabalin(HSK16149) 20mg qd po for Neurogenic rosacea（NR）
Drug: Cligabalin(HSK16149) 20mg qd
different dose
Experimental: Cligabalin（HSK16149） 20mg bid po for Neurogenic rosacea（NR）
Drug: Cligabalin(HSK16149)20mg BID
different dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CEA
Time Frame: baseline and 4w after treatment
Rosacea Facial Erythema Score
baseline and 4w after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-SR-796

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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