Real-World Study of Cligabalin(HSK16149) for the Treatmen... | NCT07606820

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

NCT07606820

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Enrolling by invitation

Last Update Posted

Jul 10, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Rosacea

Interventions

Cligabalin(HSK16149)20mg BID
Cligabalin(HSK16149) 20mg qd

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2025Actual

Primary Completion Date

Oct 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

May 19, 2026

First Submission Date that Met QC Criteria

May 19, 2026

First Posted Date

May 26, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cligabalin(HSK16149) 20mg qd po for rosacea	Experimental		Drug: Cligabalin(HSK16149) 20mg qd
Cligabalin（HSK16149） 20mg bid po for rosacea	Experimental	Cligabalin（HSK16149） 20mg bid po for rosacea	Drug: Cligabalin(HSK16149)20mg BID

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cligabalin(HSK16149)20mg BID	Drug	different dose	Cligabalin（HSK16149） 20mg bid po for rosacea

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China		Nanjing	Jiangsu		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012393	Rosacea

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided