NCT07606820

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
Last Updated

July 21, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 19, 2026

Last Update Submit

July 19, 2026

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • CEA

    Rosacea Facial Erythema Score

    baseline and 4w after treatment

Study Arms (2)

Crisugabalin(HSK16149) 20mg qd po for rosacea

EXPERIMENTAL
Drug: Crisugabalin(HSK16149) 20mg qd

Crisugabalin（HSK16149） 20mg bid po for rosacea

EXPERIMENTAL

Crisugabalin（HSK16149） 20mg bid po for rosacea

Drug: Crisugabalin(HSK16149)20mg BID

Interventions

Crisugabalin(HSK16149)20mg BIDDRUG

different dose

Crisugabalin（HSK16149） 20mg bid po for rosacea
Crisugabalin(HSK16149) 20mg qdDRUG

different dose

Crisugabalin(HSK16149) 20mg qd po for rosacea

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

October 29, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

July 21, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)