Erythematotelangiectatic Rosacea Clinical Trial
Official title:
Effects of Botulinum Toxin Type a Treatment on Clinical and Biophysical Parameters in Patients With Erythematotelangiectatic Rosacea: A Prospective, Randomized, Placebo-controlled, Double-masked Study
Verified date | March 2024 |
Source | Istanbul Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of erythema with Clinician's Erythema Assessment scale | The effect of intradermal BoNT-A treatment on facial erythema was evaluated using the Clinician's Erythema Assessment scale. | One month | |
Primary | Evaluation of erythema using mexameter | Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter. | One month | |
Primary | Evaluation of erythema by dermatoscopy | Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema. | One month | |
Secondary | Evaluation of the change in vascular structure using videocapillaroscopy | 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. | One month |
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