Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face

NCT00986570 | Completed Phase 3 Results

• 1 other identifier: XEO-001/07
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe, effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or severe expression lines (wrinkles) in the upper third of the face. The main outcome was the change in appearance of the wrinkles two weeks (visit 3) after product application as compared with baseline assessment.

Conditions

Skin Aging

Keywords

Botulinum Toxin A; Wrinkles

Outcome Measures

Primary Outcomes (1)

• Treatment Success

  Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe.

  Baseline (pre-treatment) and Visit 3 (Day 15)

Study Arms (1)

Xeomin®

EXPERIMENTAL

Botulinum Toxin A

Biological: Botulinum Toxin A

Interventions

Botulinum Toxin A BIOLOGICAL

100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.

Also known as: Xeomin®

Xeomin®

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 30 to 50 years old, inclusive.
• Mild, moderate or severe expression wrinkles.
• Patients who had understood and signed the Informed Consent Form.

You may not qualify if:

• Subjects treated with botulinum toxin on the upper third of the face within the previous 6-month period;
• Former implantation of permanent material and surgery (scars).
• Use of any anticoagulant agent up to 7 days prior to the investigational product application;
• Concomitant use of aminoglycosides or of any other drug that may impair in the neuromuscular transmission;
• Coagulopathies and local inflammation/ infection at the application site.
• Diseases which do impact on the neuromuscular function, such as: myasthenia gravis, Eaton Lambert Syndrome;
• Pregnancy or breast feeding, women with potential to become pregnant or who do not agree to use an effective contraception method (Pearl Index \< 1%);
• Allergy or known sensitivity to any of the components of the investigational drug;
• Subjects who were enrolled in other clinical trial for the last 12-month period prior to the present study, as per Resolution 251/97;
• Subjects who disagree with the study procedures, who do not sign the Informed Consent Form or who are not committed to participate in the trial.

Sponsors & Collaborators

• Biolab Sanus Farmaceutica: lead

Study Sites (1)

Universidade Federal de São Paulo/Hospital São Paulo

São Paulo, São Paulo, 04022-000, Brazil

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA

Intervention Hierarchy (Ancestors)

Botulinum Toxins; 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: Priscilla Padilha, MD
• Organization: Biolab Sanus Farmacêutica Ltda.

ppadilha@biolabfarma.com.br

55(11)35736335

Study Officials

• Sergio Talarico, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 11, 2015
• Results First Posted: December 6, 2010

Record last verified: 2015-11

Locations

BR (1)