Skip to content

Exploratory Clinical Study of Clecigabine in the Treatment of Rosacea

A Single-Arm Exploratory Study on the Efficacy of Crisugabalin in Patients with Refractory Erythematous Rosacea

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121050
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-03-25
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Interventions

Clecigabine treated group:Oral Clecigabine 20mg Once Daily

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age >= 18 years; 3. Patients who has undergone at least 12 weeks (or more) of oral treatment with any first-line medication such as antibiotics (doxycycline/minocycline/clarithromycin/azithromycin) or hydroxychloroquine, with or without other therapies (e.g., topical medications/IPL, etc.), and exhibits treatment resistance (manifested as no reduction of erythema by 1 grade, or erythema grade >= 3, or symptoms such as flushing affecting quality of life [DLQI moderate or above]); 4. Patients who experiences frequent relapses during the 12-week treatment period;

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant, breastfeeding, or planning to become pregnant in the near future; 2. Patients with systemic diseases such as diabetes, moderate to severe liver, kidney, pulmonary, or hematological disorders; 3. Patients with depression or mental disorders; 4. Patients with chronic pancreatitis; 5. Patients with rosacea accompanied by nasal hyperplasia and hypertrophy, or with other facial dermatological conditions (such as seborrheic dermatitis, eczema, etc.), or facial manifestations of other diseases (such as dermatomyositis, systemic lupus erythematosus); 6. Individuals engaged in occupations such as driving, working at heights, or operating complex machinery; 7. Patients expected to be unable to adhere to follow-up; 8. Individuals who have participated in any clinical trial within the past month; 9. Patients with known allergies to the investigational drug or its excipients; 10. Patients deemed by the investigator to be unsuitable for participation in this study;

Design outcomes

Primary

MeasureTime frame
Flushing Assessment Scale Tool (FAST);

Secondary

MeasureTime frame
Depression Anxiety Stress Scales - 21 Item (DASS-21);Clinician Erythema Assessment (CEA);VISIA Erythema Index;Rosacea Quality of Life Index (RosaQoL);

Countries

China

Contacts

Public ContactYue Zheng

Southern Medical University Southern Hospital

benbenzhu-11@163.com+86 20 62787322

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026