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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06331533
Other study ID # IstanbulTRH1
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 1, 2022
Est. completion date June 1, 2023

Study information

Verified date March 2024
Source Istanbul Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Botulinum toxin A
Intradermal botulinum toxin A was applied to the treatment side
Placebo
NaCl was injected into the placebo side

Locations

Country Name City State
Turkey Istanbul Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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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