A Phase I/II Study of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines

Moderate to Severe Glabellar Lines Clinical Trial

Official title:

A Phase I/II,Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Safety,Efficacy and Immunogenicity of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05743634
• Other study ID #: YY001-001
• Secondary ID: CTR20221419
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 22, 2022
• Est. completion date: February 13, 2023

Study information

• Verified date: February 2023
• Source: Chongqing Claruvis Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety,immunogenicity and efficacy of YY001 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The study has been designed to test the safety,efficacy,immunogenicity of YY001,and compare to onabotulinumtoxinA (BOTOX®) and placebo, in improving the appearance of moderate to severe glabellar lines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 13, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects from =18 to =65 years of age when signing an informed consent.

2. At screening and baseline,the subject has moderate to severe GL (grade of 2 or 3 on the 4-point Scale) at maximum frown when assessed by both the Investigator and the subject.

3. Agree to take part in the clinic trial and sign the informed consent form voluntarily.

4. Is able to observe the protocol by Investigator's assessment.

5. Male and female of childbearing potential agree to use a highly effective contraceptive method for the duration of the study(such as tubal ligation,abstinence,Intrauterine device,hormone,barrier method).For female of childbearing potential,her blood pregnancy test is negative within 7 days prior to study treatment,and urine pregnancy test is negative within 3 days prior to study treatment.Male can't donate the sperm within 3 months after treatment.

Exclusion Criteria:

1. Known allergy or hypersensitivity to any component of the study products(YY001 or BOTOX®).

2. Previous use of any cosmetic therapy in the glabella or forehead area,such as hyaluronic acid,phototherapy,hydrating needle,microneedle,chemical peeling,scar removal surgery or skin dermabrasion within 6 months before screening.Previous use of biodegradable filler within 12 months before screening,such as collagen,polylactic acid or calcium hydroxyapatite.Previous use of autologous fat, any permanent products (such as silicone, polyacrylamide,no matter how long the interval is) ,face-lift,or semi-permanent prosthesis.Planned use of any cosmetic therapy in the glabella or forehead area during the study(other than the study products).

3. Previous use of any botulinum toxin within 6 months prior to screening,or plan to use any botulinum toxin during the study(other than the study products).

4. Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.

5. Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.

6. Probably use of prohibited drug during the study,as assessed by the investigator.

7. Abnormal skin at in the treatment area,scar or physical scars, in the investigator's opinion,may interfere with study evaluations.

8. Inability to substantially spread glabellar lines apart by surgery or finger smoothing, as determined by the investigator.

9. Ptosis,excessive facial asymmetry and skin laxity ,at screening and baseline.

10. History of facial nerve palsy.

11. Any medical condition that may interfere neuromuscular function including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, dysphagia,dyspnea,diplopia,angle-closure glaucoma,eyelid or eyebrow ptosis,etc.

12. Any concomitant disease including,unfit for the study by the investigator.

13. In acute attack.

14. Abnormal lab findings,and unfit for the study in the opinion of the investigator.

15. History of alcohol or drug abuse.

16. History of epilepsy.

17. Any severe psychiatric illness ,in the investigator's opinion, could affect the subject's participation in the study.

18. Female who is pregnant,or breast feeding.

19. In any other clinical study ,or Participated in any other interventional study within 30 days or 5 half-lives prior to screening.

20. Contract research organization,study site personnel or close relatives of the study site personnel , employees or close relatives of employees at the sponsor company.

21. Other conditions, in the Investigator's opinion, unfit for the study.

Related Conditions & MeSH terms

• Moderate to Severe Glabellar Lines

Intervention

Biological:
• YY001
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
• OnabotulinumtoxinA
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
• Placebo
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	The First affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Nanfang Hospital,Southern Medical University	Guangzhou	Guangdong
China	Shanghai Ninth People's Hospital,Shanghai JiaoTong University school of Medicine	Shanghai	Shanghai
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Claruvis Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase1:The incidence rate of adverse events and severe adverse events within 28 days after injection		Within 28 days
Primary	Phase1:The incidence rate of injection site reaction within 28 days after injection		Within 28 days
Primary	Phase1:The incidence rate of abnormal lab findings which have clinical significance within 28 days after injection		Within 28 days
Primary	Phase2:The response rate will be evaluated at 28 days by investigator at maximum frown	A response rate is defined as a subject who achieves a score of 0 or 1 in GL severity at maximum frown and at least 2 grades improvement from baseline by investigator's assessment	28 days
Primary	Phase2:The incidence rate of adverse events and severe adverse events within 12 weeks after injection		within 12 weeks
Primary	Phase2:The incidence rate of injection site reaction within 12 weeks after injection		within 12 weeks