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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brazilan Center for Studies in Dermatology
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

1. Written Informed Consent;

2. Subjects aged between 30 and 60 years;

3. Skin Fitzpatrick Phototypes I to VI;

4. 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;

5. Subjects presenting at least two indications for treatment with BT-A in each third of the face;

6. 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;

7. 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);

8. Availability of the patient throughout the duration of the study (24 weeks);

9. Subjects that agree not to undergo other cosmetic or dermatological procedures during the study;

10. Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by the study protocol.

Exclusion Criteria:

1. Pregnant women or women intending to become pregnant during the study;

2. Subjects participating in other clinical trials;

3. Presence of scars on the face that may interfere with the result of study;

4. Subjects with neoplastic, muscular or neurological diseases;

5. Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics.

6. Subjects with inflammation or active infection in the face;

7. Subjects with a history of sensitivity to the components of the formula;

8. Subjects with prior history of eyelid ptosis; marked facial asymmetry, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.

9. Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron diseases;

10. Subjects with coagulation disorders or using anticoagulants;

11. Subjects with known systemic autoimmune diseases;

12. 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;

13. Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol.