Efficacy and Safety of a New Botulinum Toxin Type A for Treatment of Facial Expression Lines

Azidus

Status and phase: Completed; Phase 3

Conditions: Wrinkles

Treatments: Drug: Botox; Drug: Botulift

Study type: Interventional

Funder types: Industry

Identifiers

NCT01180348

TOXBER0610

Details and patient eligibility

About

The dermatological treatment for reducing facial wrinkles with injectable drug Botulift (botulinum toxin type A - Laboratório Químico Farmacêutico BergamoLtd.) has a not inferior activity when compared with Botox ® (botulinum toxin - Allergan Inc.) in clinical trials.

Full description

The study will evaluate non-inferiority in clinical improvement in the intensity of expression lines over 16 weeks of drug Botulift (Laboratório Químico Farmacêutico Bergamo Ltd.) compared with Botox ® (Allergan Inc.). So that the homogeneity of the group opted to use in female patients with glabellar wrinkles grade 2 (moderate) and 3 (severe) Scale Standard Facial Wrinkles, established by Honecker et al. (2003). The first area of the face perceived in mime is the glabellar complex, located in the space between the eyebrows, wrinkles eventually show (Almeida et al., 2010).

Patients will be evaluated at each visit, the doctor Principal Investigator and digital photos of the glabellar region at maximum contraction and relaxation will be obtained using the apparatus Visia (Canfield Imaging Systems, version 4.0.2) for further analysis by random team dermatologists.

Enrollment: 192 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who agree with all study procedures and sign for their own free will the TCLE;
• Adult patients were female between 18 and 65 years, regardless of social condition;
• between skin phototype I and IV;
• With good mental and physical health;
• Patients who have not been treated with botulinum toxin type A;
• Patients who agree to abstain from physical activity for a period of 24 hours, previous and subsequent to the initiation of the study;
• Patients presenting at screening visit, wrinkles in the glabellar region between classes 2 and 3 of Table Wrinkles Pattern Classification, which is diagnosed clinically by the dermatologist.

Exclusion criteria

• Patients who are in classes 0 and 1 of the Table Pattern Classification Wrinkle;
• Patients who have disorders or diseases that might interfere with neuromuscular function (myasthenia gravis or Lambert-Eaton syndrome);
• Patients being treated with antibiotics (aminoglycosides) and muscle relaxants;
• Patients with pre-existing conditions such as ptosis or scars in the area to be assessed, as they may endanger the health of the patient and the results of the study;
• Patients who have made treatments fill in the glabellar region (retinoic acid, collagen);
• Patients who have been treated in the dermatological peeling úlitmos three months;
• Patients are using treatments dermacosmetics agents anti age (vitamin C pure retinoids flavanoids acid hyaluronic others) or used past 3 months
• Patients with known hypersensitivity to any component of the study drug;
• Pregnant or lactating women;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

192 participants in 2 patient groups

Botulift

Experimental group

Description:

Application of 90 U of Botulift divided in 3 applications on each side of the face in fifteen predetermined sites in three regions of the face (front, glabellar, periocular).

Treatment:

Drug: Botulift

Botox

Active Comparator group

Description:

Application of 90 U of Botox divided in 3 applications on each side of the face in fifteen predetermined sites in three regions of the face (front, glabellar, periocular).

Treatment:

Drug: Botox