RosaceaNCT06282679
Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea
A study testing Botulinum Toxin Type A Injection [Botox] in people with Rosacea and Botulinum Toxin, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea, Botulinum Toxin
- What is being tested?
- Botulinum Toxin Type A Injection [Botox]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 28 Jun 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meeting the diagnostic criteria of mild to moderate erythema telangiectasis rosette acne;
- more than 18 years old;
- to obey the rules of the treatment in the study, and can be followed up for 12 weeks;
- informed consent;
Who cannot join
- Had received facial cosmetic surgery or botulinum toxin treatment within 6 months before this treatment;
- due to systemic diseases such as autoimmune diseases or menopause facial flush;
- had allergies botulinum toxin;
- pregnant or breastfeeding;
- other facial skin or oral disease therapy, including research before 4 weeks rose acne accept other treatment;
- With basic neuromuscular diseases (such as myasthenia gravis, amyotrophic lateral sclerosis, etc.);
- All landowners 4 weeks before the study whether any oral aminoglycoside drugs, benzodiazepines drugs or muscle relaxants; .Was removed during treatment observation data is not complete, incomplete treatment and patients can't take medication as prescribed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jie Dai
Nanjing, Jiangsu, 210006
jie dai, 02552271117, karry_dj@126.com
About this study
Official title: Clinical Observation of Intradermal Injections With Botulinum Toxin A in the Treatment of Rosacea Erythema Telangiectasia
the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea.
Read the detailed description
The main objective is to collect patients and then use different injection volumes of botulinum toxin intradermal injection for the treatment of rosacea erythema telangiectasia, and then to evaluate the clinical efficacy and safety of the treatment.
- Conditions
- Rosacea, Botulinum Toxin
- Being tested
- Botulinum Toxin Type A Injection [Botox]
- 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 Type A Injection [Botox]Drug
Also called follow
you are asked to return to the hospital for follow-up at weeks 2, 4, 8, and 12
| Study group | Role | What they receive |
|---|---|---|
| left cheek and right cheek | Experimental | First, apply an appropriate amount of lidocaine cream to your face and wait (30-45 minutes) for the anesthetic to take effect;
Second step, after cleaning, mark the injection site on your face, about 25-30 points on one cheek, 1 cm apart, using a randomized half face control trial, Use of botulinum toxin type A for injection (Botox) (Allergan Pharmaceticals Ireland Limited, Import Drug Registration No. : S20171003), 0.5U botulinum toxin type A (Botox) was injected per point on one cheek and 1U on the other. The total amount of botulinum toxin type A was between 15 and 30U on each side. Receives: Drug: Botulinum Toxin Type A Injection [Botox] |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEA score
Clinical erythema score (CEA) was divided into no, mild, moderate and severe according to the severity of rosacea, corresponding to 0,1,2,3, respectively
Measured: 2.4,8,12 weeks
Secondary outcomes (1)
GAIS score
he Global Aesthetic Improvement Scale (GAIS) score was assessed by the treating physician on the patient's improvement and was divided into four levels: very improved corresponding, substantial improvement, improvement, no change; Corresponding to the best beauty results, significantly improved but not the best, significantly improved, no change
Measured: 2.4,8,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Apr 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion28 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dai jie, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Jie DAI, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282679
- Sponsor's protocol ID
- KY20220701-03
- Status last verified
- Feb 2024
- First submitted
- 5 Apr 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Zuuren EJ. Rosacea. N Engl J Med. 2017 Nov 2;377(18):1754-1764. doi: 10.1056/NEJMcp1506630. No abstract available.
PubMed 29091565Marson JW, Baldwin HE. Rosacea: a wholistic review and update from pathogenesis to diagnosis and therapy. Int J Dermatol. 2020 Jun;59(6):e175-e182. doi: 10.1111/ijd.14757. Epub 2019 Dec 27.
PubMed 31880327Moustafa F, Lewallen RS, Feldman SR. The psychological impact of rosacea and the influence of current management options. J Am Acad Dermatol. 2014 Nov;71(5):973-80. doi: 10.1016/j.jaad.2014.05.036. Epub 2014 Jul 1.
PubMed 24993600Gallo RL, Granstein RD, Kang S, Mannis M, Steinhoff M, Tan J, Thiboutot D. Standard classification and pathophysiology of rosacea: The 2017 update by the National Rosacea Society Expert Committee. J Am Acad Dermatol. 2018 Jan;78(1):148-155. doi: 10.1016/j.jaad.2017.08.037. Epub 2017 Oct 28.
PubMed 29089180Bloom BS, Payongayong L, Mourin A, Goldberg DJ. Impact of intradermal abobotulinumtoxinA on facial erythema of rosacea. Dermatol Surg. 2015 Jan;41 Suppl 1:S9-16. doi: 10.1097/DSS.0000000000000277.
PubMed 25548852Schwab VD, Sulk M, Seeliger S, Nowak P, Aubert J, Mess C, Rivier M, Carlavan I, Rossio P, Metze D, Buddenkotte J, Cevikbas F, Voegel JJ, Steinhoff M. Neurovascular and neuroimmune aspects in the pathophysiology of rosacea. J Investig Dermatol Symp Proc. 2011 Dec;15(1):53-62. doi: 10.1038/jidsymp.2011.6.
PubMed 22076328Holowatz LA, Thompson CS, Minson CT, Kenney WL. Mechanisms of acetylcholine-mediated vasodilatation in young and aged human skin. J Physiol. 2005 Mar 15;563(Pt 3):965-73. doi: 10.1113/jphysiol.2004.080952. Epub 2005 Jan 20.
PubMed 15661816Choi JE, Werbel T, Wang Z, Wu CC, Yaksh TL, Di Nardo A. Botulinum toxin blocks mast cells and prevents rosacea like inflammation. J Dermatol Sci. 2019 Jan;93(1):58-64. doi: 10.1016/j.jdermsci.2018.12.004. Epub 2018 Dec 28.
PubMed 30658871Huang W, Foster JA, Rogachefsky AS. Pharmacology of botulinum toxin. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):249-59. doi: 10.1067/mjd.2000.105567.
PubMed 10906647Kim MJ, Kim JH, Cheon HI, Hur MS, Han SH, Lee YW, Choe YB, Ahn KJ. Assessment of Skin Physiology Change and Safety After Intradermal Injections With Botulinum Toxin: A Randomized, Double-Blind, Placebo-Controlled, Split-Face Pilot Study in Rosacea Patients With Facial Erythema. Dermatol Surg. 2019 Sep;45(9):1155-1162. doi: 10.1097/DSS.0000000000001819.
PubMed 30730346Dayan SH, Ashourian N, Cho K. A Pilot, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of IncobotulinumtoxinA Injections in the Treatment of Rosacea. J Drugs Dermatol. 2017 Jun 1;16(6):549-554.
PubMed 28686772Eshghi G, Khezrian L, Alirezaei P. Botulinum Toxin A in Treatment of Facial Flushing. Acta Med Iran. 2016 Jul;54(7):454-7.
PubMed 27424017Serarslan G, Makbule Kaya O, Dirican E. Scale and Pustule on Dermoscopy of Rosacea: A Diagnostic Clue for Demodex Species. Dermatol Pract Concept. 2021 Jan 29;11(1):e2021139. doi: 10.5826/dpc.1101a139. eCollection 2021 Jan.
PubMed 33614217Sharma A, Kroumpouzos G, Kassir M, Galadari H, Goren A, Grabbe S, Goldust M. Rosacea management: A comprehensive review. J Cosmet Dermatol. 2022 May;21(5):1895-1904. doi: 10.1111/jocd.14816. Epub 2022 Feb 14.
PubMed 35104917
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Intradermal Injections With Botulinum Toxin A in the Treatment of Rosacea Erythema Telangiectasia
- ClinicalTrials.gov ID
- NCT06282679
- Acronym / sponsor ID
- KY20220701-03
- Conditions
- Rosacea, Botulinum Toxin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 28 Jun 2024 (estimated)
- First posted
- 28 Feb 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.
the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea.
Detailed description
The main objective is to collect patients and then use different injection volumes of botulinum toxin intradermal injection for the treatment of rosacea erythema telangiectasia, and then to evaluate the clinical efficacy and safety of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| left cheek and right cheek | Experimental | Drug: Botulinum Toxin Type A Injection [Botox]First, apply an appropriate amount of lidocaine cream to your face and wait (30-45 minutes) for the anesthetic to take effect; Second step, after cleaning, mark the injection site on your face, about 25-30 points on one cheek, 1 cm apart, using a randomized half face control trial, Use of botulinum toxin type A for injection (Botox) (Allergan Pharmaceticals Ireland Limited, Import Drug Registration No. : S20171003), 0.5U botulinum toxin type A (Botox) was injected per point on one cheek and 1U on the other. The total amount of botulinum toxin type A was between 15 and 30U on each side. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meeting the diagnostic criteria of mild to moderate erythema telangiectasis rosette acne;
- more than 18 years old;
- to obey the rules of the treatment in the study, and can be followed up for 12 weeks;
- informed consent;
Key exclusion criteria (7 listed)
- Had received facial cosmetic surgery or botulinum toxin treatment within 6 months before this treatment;
- due to systemic diseases such as autoimmune diseases or menopause facial flush;
- had allergies botulinum toxin;
- pregnant or breastfeeding;
- other facial skin or oral disease therapy, including research before 4 weeks rose acne accept other treatment;
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 Type A Injection [Botox]Also: followyou are asked to return to the hospital for follow-up at weeks 2, 4, 8, and 12 | Drug | left cheek and right cheek |
Primary outcome
CEA score
Time frame: 2.4,8,12 weeks
Clinical erythema score (CEA) was divided into no, mild, moderate and severe according to the severity of rosacea, corresponding to 0,1,2,3, respectively
1 secondary outcome
GAIS score
Time frame: 2.4,8,12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Results publication: PubMed 29091565van Zuuren EJ. Rosacea. N Engl J Med. 2017 Nov 2;377(18):1754-1764. doi: 10.1056/NEJMcp1506630. No abstract available.
- Results publication: PubMed 31880327Marson JW, Baldwin HE. Rosacea: a wholistic review and update from pathogenesis to diagnosis and therapy. Int J Dermatol. 2020 Jun;59(6):e175-e182. doi: 10.1111/ijd.14757. Epub 2019 Dec 27.
- Results publication: PubMed 24993600Moustafa F, Lewallen RS, Feldman SR. The psychological impact of rosacea and the influence of current management options. J Am Acad Dermatol. 2014 Nov;71(5):973-80. doi: 10.1016/j.jaad.2014.05.036. Epub 2014 Jul 1.
- Results publication: PubMed 29089180Gallo RL, Granstein RD, Kang S, Mannis M, Steinhoff M, Tan J, Thiboutot D. Standard classification and pathophysiology of rosacea: The 2017 update by the National Rosacea Society Expert Committee. J Am Acad Dermatol. 2018 Jan;78(1):148-155. doi: 10.1016/j.jaad.2017.08.037. Epub 2017 Oct 28.
- Results publication: PubMed 25548852Bloom BS, Payongayong L, Mourin A, Goldberg DJ. Impact of intradermal abobotulinumtoxinA on facial erythema of rosacea. Dermatol Surg. 2015 Jan;41 Suppl 1:S9-16. doi: 10.1097/DSS.0000000000000277.
- Results publication: PubMed 22076328Schwab VD, Sulk M, Seeliger S, Nowak P, Aubert J, Mess C, Rivier M, Carlavan I, Rossio P, Metze D, Buddenkotte J, Cevikbas F, Voegel JJ, Steinhoff M. Neurovascular and neuroimmune aspects in the pathophysiology of rosacea. J Investig Dermatol Symp Proc. 2011 Dec;15(1):53-62. doi: 10.1038/jidsymp.2011.6.
- Results publication: PubMed 15661816Holowatz LA, Thompson CS, Minson CT, Kenney WL. Mechanisms of acetylcholine-mediated vasodilatation in young and aged human skin. J Physiol. 2005 Mar 15;563(Pt 3):965-73. doi: 10.1113/jphysiol.2004.080952. Epub 2005 Jan 20.
- Results publication: PubMed 30658871Choi JE, Werbel T, Wang Z, Wu CC, Yaksh TL, Di Nardo A. Botulinum toxin blocks mast cells and prevents rosacea like inflammation. J Dermatol Sci. 2019 Jan;93(1):58-64. doi: 10.1016/j.jdermsci.2018.12.004. Epub 2018 Dec 28.
- Results publication: PubMed 10906647Huang W, Foster JA, Rogachefsky AS. Pharmacology of botulinum toxin. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):249-59. doi: 10.1067/mjd.2000.105567.
- Results publication: PubMed 30730346Kim MJ, Kim JH, Cheon HI, Hur MS, Han SH, Lee YW, Choe YB, Ahn KJ. Assessment of Skin Physiology Change and Safety After Intradermal Injections With Botulinum Toxin: A Randomized, Double-Blind, Placebo-Controlled, Split-Face Pilot Study in Rosacea Patients With Facial Erythema. Dermatol Surg. 2019 Sep;45(9):1155-1162. doi: 10.1097/DSS.0000000000001819.
- Results publication: PubMed 28686772Dayan SH, Ashourian N, Cho K. A Pilot, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of IncobotulinumtoxinA Injections in the Treatment of Rosacea. J Drugs Dermatol. 2017 Jun 1;16(6):549-554.
- Results publication: PubMed 27424017Eshghi G, Khezrian L, Alirezaei P. Botulinum Toxin A in Treatment of Facial Flushing. Acta Med Iran. 2016 Jul;54(7):454-7.
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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.
Jie DAI study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A Injection [Botox] in people with Rosacea and Botulinum Toxin, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Feb 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Dai (02552271117, karry_dj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CEA score (time frame: 2.4,8,12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06282679, which also lists 14 linked publications.
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 28 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.