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

NCT06282679 | Recruiting

• 1 other identifier: KY20220701-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rosacea; Botulinum Toxin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• GAIS score

  2.4,8,12 weeks

Other Outcomes (2)

• VISIA red zone score

  2.4,8,12 weeks

• Dermatology Quality of Life Score (DLQI)

  2.4,8,12 weeks

Study Arms (1)

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.

Drug: Botulinum Toxin Type A Injection [Botox]

Interventions

Botulinum Toxin Type A Injection [Botox] DRUG

you are asked to return to the hospital for follow-up at weeks 2, 4, 8, and 12

Also known as: follow

left cheek and right cheek

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Jie Dai

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (14)

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

  PMID: 29091565 RESULT

• 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.

  PMID: 31880327 RESULT

• 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.

  PMID: 24993600 RESULT

• 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.jaad.2017.08.037. Epub 2017 Oct 28.

  PMID: 29089180 RESULT

• 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.

  PMID: 25548852 RESULT

• 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. 2011 Dec;15(1):53-62. doi: 10.1038/jidsymp.2011.6.

  PMID: 22076328 RESULT

• 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.

  PMID: 15661816 RESULT

• 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.

  PMID: 30658871 RESULT

• 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.

  PMID: 10906647 RESULT

• 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 Patients With Facial Erythema. Dermatol Surg. 2019 Sep;45(9):1155-1162. doi: 10.1097/DSS.0000000000001819.

  PMID: 30730346 RESULT

• 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.

  PMID: 28686772 RESULT

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

  PMID: 27424017 RESULT

• 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.

  PMID: 33614217 RESULT

• 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.

  PMID: 35104917 RESULT

MeSH Terms

Conditions

Rosacea

Interventions

Botulinum Toxins, Type A

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

Study Officials

• Jie DAI

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Jie Dai

CONTACT

02552271117; karry_dj@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nanjing First Hospital

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: February 28, 2024
• Study Start: April 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: June 28, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (1)