A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides

Glabellar Rhytides Clinical Trial

Official title:

Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Forehead and Glabellar Facial Rhytides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261467
• Other study ID #: 191622-142
• Secondary ID: 2014-001860-36
• Status: Completed
• Phase: Phase 3
• Start date: October 21, 2014
• Est. completion date: April 26, 2016

Study information

• Verified date: December 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: April 26, 2016
• Est. primary completion date: June 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to severe forehead and glabellar lines

• Willing to have facial photos taken

Exclusion Criteria:

• Prior exposure to botulinum toxin of any serotype for any indication

• Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment

• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

• Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months

• Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months

• Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year

• Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)

• Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation

Related Conditions & MeSH terms

• Forehead Rhytides
• Glabellar Rhytides

Intervention

Biological:
• OnabotulinumtoxinA
OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.

Drug:
• Normal Saline
Placebo (normal saline) injected into the protocol-specified areas on Day 1.

Locations

Country	Name	City	State
Canada	Sweat Clinics of Canada	Toronto	Ontario
Canada	Carruthers Dermatology Centre	Vancouver	British Columbia
Canada	Dr. Shannon Humphrey, Inc.	Vancouver	British Columbia
Canada	Jean Carruthers Cosmetic Dermatology	Vancouver	British Columbia
Canada	Arthur Swift Research, Inc.	Westmount	Quebec
Ireland	Aesthetic Surgery Ireland	Dublin
Ireland	Beacon Face and Dermatology Clinic	Dublin
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	Steven Fagien, MD, PA	Boca Raton	Florida
United States	Laser & Skin Surgery Center of Indiana	Carmel	Indiana
United States	Advanced Research Associates	Glendale	Arizona
United States	About Skin Dermatology and DermSurgery, PC	Greenwood Village	Colorado
United States	Coleman Center For Cosmetic Dermatologic Surgery	Metairie	Louisiana
United States	NW Dermatology and Research Center	Portland	Oregon
United States	Clinical Science Institute	Santa Monica	California
United States	Henry Ford Medical Center	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada,  Ireland, 

References & Publications (1)

De Boulle K, Werschler WP, Gold MH, Bruce S, Sattler G, Ogilvie P, Street J, Larsen KE, Yushmanova I, Lei X, Lee E, Vitarella D, Mao C. Phase 3 Study of OnabotulinumtoxinA Distributed Between Frontalis, Glabellar Complex, and Lateral Canthal Areas for Treatment of Upper Facial Lines. Dermatol Surg. 2018 Nov;44(11):1437-1448. doi: 10.1097/DSS.0000000000001612. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With =2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation	The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.	Baseline, Day 30
Secondary	Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation	The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of "none" and "mild" are reported.	Day 30
Secondary	Percentage of Subjects With =1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest	The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.	Baseline, Day 30
Secondary	Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5	The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks "How satisfied are you with the effect your treatment had on your facial lines?" Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported.	Day 60
Secondary	Percentage of Subjects With =20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score = 20 Points	The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject's appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores = 20 are included in the analysis.	Baseline, Day 30
Secondary	Percentage of Subjects With a =3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©	The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is "I look older than my actual age because of my facial lines" with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores = 3 are included in the analysis.	Baseline, Day 30
Secondary	Time to Retreatment Eligibility	Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a = 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.	12 Months