Erythematotelangiectatic Rosacea
Conditions
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.
Interventions
DRUGBotulinum toxin A
Intradermal botulinum toxin A was applied to the treatment side
DRUGPlacebo
NaCl was injected into the placebo side
Sponsors
Istanbul Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Botulinum toxin will be injected into one randomly selected half of the face, and placebo will be injected into the other half of the face. The patient will not know which half of the face was treated. An independent, blinded dermatologist will evaluate the results of the treatment.
Intervention model description
Randomized, split face, efficacy study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 18-60 years old * Erythematotelangiectatic rosacea subtype * Willingness to participate in the research and providing informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 using mexameter | One month | Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter. |
| Evaluation of erythema by dermatoscopy | One month | Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed