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

February 20, 2024 updated by: dai jie, Nanjing First Hospital, Nanjing Medical University

Clinical Observation of Intradermal Injections With Botulinum Toxin A in the Treatment of Rosacea Erythema Telangiectasia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Recruiting
        • Jie Dai
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: left cheek and right cheek

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.
Drug: Botulinum Toxin Type A Injection [Botox]
you are asked to return to the hospital for follow-up at weeks 2, 4, 8, and 12
Other Names:
  • follow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CEA score
Time Frame: 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
2.4,8,12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GAIS score
Time Frame: 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
2.4,8,12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
VISIA red zone score
Time Frame: 2.4,8,12 weeks
VISIA Red zone score The patient's face was photographed by VISIA analyzer and corresponding indicators such as feature index and percentage were recorded
2.4,8,12 weeks
Dermatology Quality of Life Score (DLQI)
Time Frame: 2.4,8,12 weeks
The Dermatology Life Quality Score (DLQI) is scored by answering multiple questions in which patients self-rate the impact of their current illness on their lives over a period of one week. The answer is divided into four levels, very serious 3 points, severe 2 points, a little 1 point, no 0 points;
2.4,8,12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Director: Jie DAI, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 28, 2024

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20220701-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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