Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea

Not Applicable

Recruiting

• Conditions: Rosacea; Botulinum Toxin
• Interventions: Drug: Botulinum Toxin Type A Injection [Botox]

• Registration Number: NCT06282679
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea.

Detailed Description

The main objective is to collect patients and then use different injection volumes of botulinum toxin intradermal injection for the treatment of rosacea erythema telangiectasia, and then to evaluate the clinical efficacy and safety of the treatment.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2023-04-05
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-03-01
• Study Completion: 2024-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• Had received facial cosmetic surgery or botulinum toxin treatment within 6 months before this treatment;
• due to systemic diseases such as autoimmune diseases or menopause facial flush;
• had allergies botulinum toxin;
• pregnant or breastfeeding;
• other facial skin or oral disease therapy, including research before 4 weeks rose acne accept other treatment;
• With basic neuromuscular diseases (such as myasthenia gravis, amyotrophic lateral sclerosis, etc.);
• All landowners 4 weeks before the study whether any oral aminoglycoside drugs, benzodiazepines drugs or muscle relaxants; .Was removed during treatment observation data is not complete, incomplete treatment and patients can't take medication as prescribed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
left cheek and right cheek	Botulinum Toxin Type A Injection [Botox]	First, apply an appropriate amount of lidocaine cream to your face and wait (30-45 minutes) for the anesthetic to take effect; Second step, after cleaning, mark the injection site on your face, about 25-30 points on one cheek, 1 cm apart, using a randomized half face control trial, Use of botulinum toxin type A for injection (Botox) (Allergan Pharmaceticals Ireland Limited, Import Drug Registration No. : S20171003), 0.5U botulinum toxin type A (Botox) was injected per point on one cheek and 1U on the other. The total amount of botulinum toxin type A was between 15 and 30U on each side.

Primary Outcome Measures

Name	Time	Method
CEA score	2.4,8,12 weeks	Clinical erythema score (CEA) was divided into no, mild, moderate and severe according to the severity of rosacea, corresponding to 0,1,2,3, respectively

Secondary Outcome Measures

Name	Time	Method
GAIS score	2.4,8,12 weeks	he Global Aesthetic Improvement Scale (GAIS) score was assessed by the treating physician on the patient's improvement and was divided into four levels: very improved corresponding, substantial improvement, improvement, no change; Corresponding to the best beauty results, significantly improved but not the best, significantly improved, no change

Trial Locations

Locations (1)

Jie Dai; 🇨🇳 Nanjing, Jiangsu, China