Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea

NCT06331533 | Completed Phase 4

• 1 other identifier: IstanbulTRH1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythematotelangiectatic Rosacea

Outcome Measures

Primary Outcomes (3)

• 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

• Evaluation of erythema using mexameter

  Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter.

  One month

• Evaluation of erythema by dermatoscopy

  Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema.

  One month

Secondary Outcomes (1)

• Evaluation of the change in vascular structure using videocapillaroscopy

  One month

Study Arms (2)

Botulinum toxin A

EXPERIMENTAL

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.

Drug: Botulinum toxin A

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Botulinum toxin A DRUG

Intradermal botulinum toxin A was applied to the treatment side

Also known as: Botox

Botulinum toxin A

Placebo DRUG

NaCl was injected into the placebo side

Also known as: %0.9 Sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Erythematotelangiectatic rosacea subtype
• Willingness to participate in the research and providing informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rosacea

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, split face, efficacy study

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 26, 2024
• Study Start: November 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)