Erythematotelangiectatic RosaceaPhase 4NCT06331533
Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea
A Phase 4 study testing Botulinum toxin A in people with Erythematotelangiectatic Rosacea, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Erythematotelangiectatic Rosacea
- What is being tested?
- Botulinum toxin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old
- Erythematotelangiectatic rosacea subtype
- Willingness to participate in the research and providing informed consent
Who cannot join
- 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
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- Reporting allergy to the active ingredient
- Pregnant or breastfeeding patients
- Patients who do not accept treatment and follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, 34098
About this study
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
Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy.
Read the 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.
- Conditions
- Erythematotelangiectatic Rosacea
- Being tested
- Botulinum toxin A, Placebo
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin ADrug
Also called Botox
Intradermal botulinum toxin A was applied to the treatment side
PlaceboDrug
Also called %0.9 Sodium chloride
NaCl was injected into the placebo side
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month
Evaluation of erythema using mexameter
Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter.
Measured: One month
Evaluation of erythema by dermatoscopy
Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema.
Measured: One month
Secondary outcomes (1)
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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Nov 2022
- Primary completion1 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythematotelangiectatic RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized, split face, efficacy study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Buğra Burç Dağtaş, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331533
- Sponsor's protocol ID
- IstanbulTRH1
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06331533
- Acronym / sponsor ID
- IstanbulTRH1
- Conditions
- Erythematotelangiectatic Rosacea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, split face, efficacy study
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A | Experimental | Drug: Botulinum toxin A30 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. |
| Placebo | Placebo comparator | Drug: Placebo30 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years old
- Erythematotelangiectatic rosacea subtype
- Willingness to participate in the research and providing informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin AAlso: BotoxIntradermal botulinum toxin A was applied to the treatment side | Drug | Botulinum toxin A |
| PlaceboAlso: %0.9 Sodium chlorideNaCl was injected into the placebo side | Drug | Placebo |
Primary outcome
Assessment of erythema with Clinician's Erythema Assessment scale
Time frame: 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
Time frame: One month
Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter.
Evaluation of erythema by dermatoscopy
Time frame: One month
Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema.
1 secondary outcome
Evaluation of the change in vascular structure using videocapillaroscopy
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin A in people with Erythematotelangiectatic Rosacea, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of erythema with Clinician's Erythema Assessment scale (time frame: One month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.