Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea
- Conditions
- Erythematotelangiectatic Rosacea
- Interventions
- Drug: Placebo
- Registration Number
- NCT06331533
- Lead Sponsor
- Istanbul Training and Research Hospital
- Brief Summary
Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy.
- Detailed Description
There is no gold standard treatment for erythematotelangiectatic rosacea (ETR). In recent years, some studies have been conducted to demonstrate the efficacy of intradermal botulinum toxin A (BoNT-A) treatment in ETR and facial erythema. Studies including objective and quantitative measurements are limited.
This study aims to investigate the efficacy and safety of intradermal BoNT-A treatment in ETR patients.
This randomised, double-blind, split-face study included 30 participants with erythematotelangiectatic rosacea (ETR). They were randomly randomised to intradermal BoNT-A on one side of the face and placebo on the other side. Clinician's erythema assessment (CEA) score, patient self-assessment (PSA) score, erythema index (EI), melanin index (MI), dermatoscopic and capillaroscopic analyses of background erythema and vascular structure were assessed at baseline and one month after treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 18-60 years old
- Erythematotelangiectatic rosacea subtype
- Willingness to participate in the research and providing informed consent
- Patients under 18 years of age, over 60 years of age
- A rosacea subtype other than ETR
- History of using topical or systemic medications within the past two weeks due to rosacea or other dermatoses
- Known history of autoimmune disease
- History of neuromuscular disease
- History of facial botulinum toxin injection within the last six months
- Reporting allergy to the active ingredient
- Pregnant or breastfeeding patients
- Patients who do not accept treatment and follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo 30 points were marked on a randomly selected face half at 0.5 cm intervals. 1.5 ml isotonic NaCl was injected intradermally into 30 points. Botulinum toxin A Botulinum toxin A 30 points were marked on a randomly selected face half at 0.5 cm intervals. 0.5 U BoNT-A was injected into each point, making a total of 15 U BoNT-A.
- Primary Outcome Measures
Name Time Method Evaluation of erythema using mexameter One month Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter.
Assessment of erythema with Clinician's Erythema Assessment scale One month The effect of intradermal BoNT-A treatment on facial erythema was evaluated using the Clinician's Erythema Assessment scale.
Evaluation of erythema by dermatoscopy One month Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema.
- Secondary Outcome Measures
Name Time Method Evaluation of the change in vascular structure using videocapillaroscopy One month The secondary objective of the study was to examine the effect of intradermal BoNT-A treatment on the Investigator Global Assessment (poorly defined vasculature and increased vessel diameter were considered poor response; IGA score=-1, localized or complete obliteration of vascular structures was considered good; IGA score=1, no change in vascular structures was considered no response; IGA score=0) scale developed using videocapillaroscopy.
Trial Locations
- Locations (1)
Istanbul Training and Research Hospital
🇹🇷Istanbul, Turkey