Clinical trial NCT06282679: Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea
Official title: Clinical Observation of Intradermal Injections With Botulinum Toxin A in the Treatment of Rosacea Erythema Telangiectasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rosacea
Botulinum Toxin
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

* Meeting the diagnostic criteria of mild to moderate erythema telangiectasis rosette acne;
* more than 18 years old;
* to obey the rules of the treatment in the study, and can be followed up for 12 weeks;
* informed consent;

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.

Primary outcomes:
measure: CEA score
timeFrame: 2.4,8,12 weeks
Secondary outcomes:
measure: GAIS score
timeFrame: 2.4,8,12 weeks
Other outcomes:
measure: VISIA red zone score
timeFrame: 2.4,8,12 weeks
measure: Dermatology Quality of Life Score (DLQI)
timeFrame: 2.4,8,12 weeks
Locations:
city: Nanjing
country: China
facility: Jie Dai
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jie DAI
role: STUDY_DIRECTOR
References:
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