Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea

Rosacea Clinical Trial

Official title:

Clinical Observation of Intradermal Injections With Botulinum Toxin A in the Treatment of Rosacea Erythema Telangiectasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282679
• Other study ID #: KY20220701-03
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: June 28, 2024

Study information

• Verified date: February 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jie Dai
• Phone: 02552271117
• Email: karry_dj[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 28, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria

• 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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Botulinum Toxin
• Rosacea

Intervention

Drug:
• Botulinum Toxin Type A Injection [Botox]
you are asked to return to the hospital for follow-up at weeks 2, 4, 8, and 12

Locations

Country	Name	City	State
China	Jie Dai	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (14)

Bloom 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. — View Citation

Choi 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. — View Citation

Dayan 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. — View Citation

Eshghi G, Khezrian L, Alirezaei P. Botulinum Toxin A in Treatment of Facial Flushing. Acta Med Iran. 2016 Jul;54(7):454-7. — View Citation

Gallo 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 — View Citation

Holowatz 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. — View Citation

Huang 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. — View Citation

Kim 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 Patient — View Citation

Marson 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. — View Citation

Moustafa 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. — View Citation

Schwab 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. 2 — View Citation

Serarslan 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. — View Citation

Sharma 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. — View Citation

van Zuuren EJ. Rosacea. N Engl J Med. 2017 Nov 2;377(18):1754-1764. doi: 10.1056/NEJMcp1506630. No abstract available. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VISIA red zone score	VISIA Red zone score The patient's face was photographed by VISIA analyzer and corresponding indicators such as feature index and percentage were recorded	2.4,8,12 weeks
Other	Dermatology Quality of Life Score (DLQI)	The Dermatology Life Quality Score (DLQI) is scored by answering multiple questions in which patients self-rate the impact of their current illness on their lives over a period of one week. The answer is divided into four levels, very serious 3 points, severe 2 points, a little 1 point, no 0 points;	2.4,8,12 weeks
Primary	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	2.4,8,12 weeks
Secondary	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	2.4,8,12 weeks