Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®)

NCT01032954 | Completed Phase 4 Results

• 1 other identifier: 01-CBED09-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label and phase IV study of full face injections of variable doses of botulinum toxin type A (BT-A). As it is an open-label and not blind study, both investigator and subjects will know the injection local and doses of the study drug. Patients will be randomized into 3 different groups. Each group will receive a specific dose according with the indication evaluated by the investigator. Six visits will be schedule in this study.

Conditions

Sun-induced Wrinkles

Keywords

Botulinum Toxin; Rejuvenation; Facial dynamic wrinkles

Outcome Measures

Primary Outcomes (3)

• Wrinkles' Severity (Forehead)

  Facial Wrinkle Scale: 0 - none, 1 - mild; 2 - moderate; 3 - severe

  Baseline; Week 4; Week 16; Week 20; Week 24

• Wrinkles' Severity (Glabella)

  GLADYS study Atlas: 0 - no wrinkles, 1 - mild wrinkles; 2 - moderate wrinkles; 3 - severe wrinkles

  Baseline; Week 4; Week 16; Week 20; Week 24

• Wrinkles' Severity (Periocular [Crow's Feet])

  Photonumeric Atlas for the Assessment of Crow's Feet Severity: 0 - none, 1 - mild; 2 - moderate; 3 - severe

  Baseline; Week 4; Week 16; Week 20; Week 24

Study Arms (3)

125 to 170 IU of "'Botulinum toxin' "

ACTIVE COMPARATOR

group with intervention of 125 to 170 IU of 'Botulinum toxin'

Drug: Botulinum toxin

171 to 210 IU of 'Botulinum toxin'

ACTIVE COMPARATOR

Patients who have received 171 to 210 IU of 'Botulinum toxin'

Drug: Botulinum toxin

211 to 250 IU of Botulinum toxin

ACTIVE COMPARATOR

Patients who have received 211 to 250 U of Botulinum toxi'

Drug: Botulinum toxin

Interventions

Botulinum toxin DRUG

Drug: Botulinum toxin Indications for eligibility and total doses that will be applied in each part of the face, at visit 1: Upper face: * Crow's feet wrinkles - 70 units * Glabella - 50 units * Forehead - 40 units Mid face: * Lower eyelid - 5 units * Nasal wrinkles - 20 units * Malar wrinkles - 10 units Lower face: * Peri-oral wrinkles - 15 units * Asymmetric smile or gummy smile - 5 units * "Cellulitic chin" - 20 units * Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected. Patients will be allocated in each group and receive the doses described above at visit 1. At visit 2, all the patients will receive a touch-up of a standard dose of 25 U, distributed on the treated areas according patient's needs.

Also known as: Dysport

125 to 170 IU of "'Botulinum toxin' "; 171 to 210 IU of 'Botulinum toxin'; 211 to 250 IU of Botulinum toxin

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written Informed Consent;
• Subjects aged between 30 and 60 years;
• Skin Fitzpatrick Phototypes I to VI;
• Subjects that never received BT-A or who had previous injections of BT-A in no more than one third of the face with in the last 6 months;
• Subjects presenting at least two indications for treatment with BT-A in each third of the face;
• Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation;
• Subjects of childbearing age should present a negative urine pregnancy test (instant test) at baseline and should be using an effective contraceptive method (oral or injectable contraceptive, for at last three months, and use of preservative; subjects with: hysterectomy, oophorectomy or tubal ligation);
• Availability of the patient throughout the duration of the study (24 weeks);
• Subjects that agree not to undergo other cosmetic or dermatological procedures during the study;
• Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by the study protocol.

You may not qualify if:

• Pregnant women or women intending to become pregnant during the study;
• Subjects participating in other clinical trials;
• Presence of scars on the face that may interfere with the result of study;
• Subjects with neoplastic, muscular or neurological diseases;
• Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics.
• Subjects with inflammation or active infection in the face;
• Subjects with a history of sensitivity to the components of the formula;
• Subjects with prior history of eyelid ptosis; marked facial asymmetry, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
• Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron diseases;
• Subjects with coagulation disorders or using anticoagulants;
• Subjects with known systemic autoimmune diseases;
• Subjects clinically diagnosed anxiety disorder or any significant psychiatric disorder (e.g. depression) that, in the opinion of the Evaluator, might interfere with the Subject's participation in the study;
• Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol.

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead

Study Sites (1)

Brazilian Center for Studies in Dermatology

Porto Alegre, Rio Grande do Sul, 90570-040, Brazil

Location

MeSH Terms

Interventions

Botulinum Toxins; abobotulinumtoxinA

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr Doris Hexsel
• Organization: Brazilian Center for Studies in Dermatology

cientifico@cbed.org.br

555130262633

Study Officials

• Doris M Hexsel, MD

  Brazilian Center for Studies in Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 14, 2020
• Results First Posted: September 17, 2020

Record last verified: 2020-09

Locations

BR (1)