An interventional study of Botulinum Toxin Type A Injection [Botox] in Rosacea and Botulinum Toxin, sponsored by Nanjing First Hospital, Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Treatment
the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea.
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's planned enrollment of 30 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 224 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: follow
CEA score
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
Time frame: 2.4,8,12 weeks
GAIS score
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
Time frame: 2.4,8,12 weeks
VISIA red zone score
VISIA Red zone score The patient's face was photographed by VISIA analyzer and corresponding indicators such as feature index and percentage were recorded
Time frame: 2.4,8,12 weeks
Dermatology Quality of Life Score (DLQI)
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;
Time frame: 2.4,8,12 weeks
Started Apr 2022 (actual). Primary completion is estimated for Mar 2024, 23 months after the start.
Of 42 interventional studies with no phase under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 23 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Botulinum toxin type A
Nanjing First Hospital, Nanjing Medical University →