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

IstanbulTRH1

Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy.

2022-11-01

2023-05-01

2023-06-01

Completed

Early phase I

30

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Randomized, split face, efficacy study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2024-03-29