NCT07606820

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress12%
May 2026Dec 2026

First Submitted

Initial submission to the registry

May 19, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 20, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 19, 2026

Last Update Submit

May 29, 2026

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • CEA

    Rosacea Facial Erythema Score

    baseline and 4w after treatment

Study Arms (2)

Cligabalin(HSK16149) 20mg qd po for Neurogenic rosacea（NR）

EXPERIMENTAL
Drug: Cligabalin(HSK16149) 20mg qd

Cligabalin（HSK16149） 20mg bid po for Neurogenic rosacea（NR）

EXPERIMENTAL

Cligabalin（HSK16149） 20mg bid po for Neurogenic rosacea（NR）

Drug: Cligabalin(HSK16149)20mg BID

Interventions

Cligabalin(HSK16149)20mg BIDDRUG

different dose

Cligabalin（HSK16149） 20mg bid po for Neurogenic rosacea（NR）
Cligabalin(HSK16149) 20mg qdDRUG

different dose

Cligabalin(HSK16149) 20mg qd po for Neurogenic rosacea（NR）

Eligibility Criteria

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

You may not qualify if:

  • 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.

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
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

May 20, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

June 2, 2026

Record last verified: 2026-05

Locations

CN(1)