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The treatment of rosacea with Botulinus Toxin A: a self-controlled study

The treatment of rosacea with Botulinus Toxin A: a self-controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035925
Enrollment
Unknown
Registered
2020-08-20
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

Rosacea

Interventions

Intervention side:Intralesional injection of 10U of Botulinus Toxin A
Contral side:Intralesional injection of equal volume of normal saline

Sponsors

Shanghai Skin Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female aged 18 to 65 years with clinical diagnosis of rosacea; 2. Those who have not received any medication or photoelectric treatment for rosacea within 3 months, and have no plan to have any facial skin surgery or treatment within half a year; 3. The subjects have good compliance, can and are willing to follow the research guidance and the treatment restrictions specified in this protocol, and can complete all the study visits as required; 4. Read and sign the informed consent form before the study.

Exclusion criteria

Exclusion criteria: 1. There are other facial inflammatory diseases in the treatment site: solar dermatitis, facial eczema, facial contact dermatitis, facial recurrent dermatitis, lupus erythematosus, dermatomyositis, etc; 2. Fever (body temperature above 37.5 degree C) or clinical active infection that significantly affects clinical trials; 3. Scar constitution; 4. Skin tumor was found in the treatment site; 5. Exposure history in recent month; 6. Have a history of injection of fillers in the past two weeks; 7. Grinding history in recent half a year; 8. Malignant tumor of systemic organs and blood system and malignant tumor; 9. Have a history of HIV infection or HIV antibody positive, or have a history of HSV attack in the treatment site in recent three months; 10. Low immune function and systemic failure; serious heart, liver, lung, kidney and other important organ diseases are not suitable to participate in clinical trials, such as renal insufficiency requiring dialysis or renal transplantation; 11. Poor glycemic control in diabetes mellitus (fasting blood glucose > 7.0mmol/l, postprandial 2-hour blood glucose > 11.1mmol/l, A1C > 6.5%); 12. Hematological diseases, including hematological neoplasms, abnormal coagulation function and severe hematopoietic dysfunction; 13. Drug, tobacco and alcohol addiction; 14. Have a clear history of mental illness; 15. Participated in any other clinical study within 1 month (or 5 half-life time of the trial drug) before enrollment; 16. Taking glucocorticoids or other immunosuppressants, anticoagulants, or suffering from autoimmune diseases; 17. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Erythema index and transdermal water loss;

Countries

China

Contacts

Public ContactWenxin Dong

Shanghai Skin Disease Hospital

dongwenxin_1989@hotmail.com+86 13801789421

Outcome results

None listed

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