ClinicalTrials.gg
CompletedNCT07606820Updated Jul 21, 2026

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

An interventional study of Crisugabalin(HSK16149)20mg BID and Crisugabalin(HSK16149) 20mg qd in Rosacea, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2025, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

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

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Conditions studied

  • Rosacea

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03

In context

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

This study's enrollment of 30 is below the median of 61 across 200 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • facial erythema despite conventional treatment, including antibiotics (metronidazole, doxycycline, and minocycline), oral isotretinoin, and oral beta-blockers.

Exclusion criteria

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 or retinoids.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Crisugabalin(HSK16149) 20mg qd po for rosacea

    Drug: Crisugabalin(HSK16149) 20mg qd

  • Experimental
    Crisugabalin(HSK16149) 20mg bid po for rosacea

    Crisugabalin(HSK16149) 20mg bid po for rosacea

    Drug: Crisugabalin(HSK16149)20mg BID

Interventions

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What researchers measure

Primary outcomes

  1. CEA

    Rosacea Facial Erythema Score

    Time frame: baseline and 4w after treatment

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Study locations

1 site
  • Department of Dermatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China
    Nanjing, Jiangsu, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07606820
Responsible party
Sponsor
First posted
May 26, 2026
Start date
Oct 29, 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026
Last update
Jul 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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