Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum

NCT01728337 | Completed Phase 4 Results

• 1 other identifier: 12-2012
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin).

Conditions

Sun-induced Wrinkles

Keywords

botulinum toxin,; wrinkles

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders After 5 Months After the Procedure

  Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline. WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles.

  5 months after intervention

Secondary Outcomes (1)

• Maximum Evoked Compound Muscle Action Potential

  5 months after the procedure.

Study Arms (2)

Dysport and Xeomin

ACTIVE COMPARATOR

30 U of Dysport® was injected on the right side of the forehead and 12 U Xeomin® was injected on the left side of the forehead (dose-equivalence 2.5:1).

Drug: Dysport; Drug: Xeomin

Xeomin and Dysport

ACTIVE COMPARATOR

30 U Dysport® was injected on the left side of the forehead and 12 U Xeomin® was injected on the right side of the forehead (dose-equivalence 2.5:1).

Drug: Dysport; Drug: Xeomin

Interventions

Dysport DRUG

Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.

Also known as: botulinum toxin type A

Dysport and Xeomin; Xeomin and Dysport

Xeomin DRUG

Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead

Also known as: botulinum toxin type A

Dysport and Xeomin; Xeomin and Dysport

Eligibility Criteria

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

You may qualify if:

• Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
• Female subjects;
• Phototype I to IV;
• Subjects aged between 18 and 60 years;
• Subjects naive for BT-A treatment;
• Subjects presenting the same degree of moderate (2) to severe (3) wrinkles on the left and right side of forehead under maximum voluntary contraction of the frontalis m. according WSS;
• Subjects with Minor's test showing at least grade III in the Sweating Intensity Visual Scale;
• Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation;
• Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study;
• Availability of the subject throughout the study (5 months);
• Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study;
• Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol.

You may not qualify if:

• Pregnant women or women intending to become pregnant in the following 5 months after screening;
• Lactation period;
• Subjects participating in other clinical trials;
• Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharoplasty or brow lift;
• Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results;
• Subjects with neoplastic, muscular or neurological diseases;
• Subjects taking aminoglycoside and penicillamine antibiotics, quinine or Ca2+ channel blockers;
• Subjects with inflammation or active infection in the area to be injected;
• Subjects presenting evident facial asymmetry;
• Subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula, ptosis or any other adverse effect which, in the investigator's opinion, should prevent the subject from participating in the study;
• Subjects presenting Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron disease;
• Subjects with coagulation disorders or taking anticoagulants;
• Subjects with known systemic autoimmune diseases;
• Subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol;
• Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead

Study Sites (1)

Brazilian Center For Studies in Dermatology

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Interventions

abobotulinumtoxinA; 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: Dr Doris Hexsel
• Organization: CBED

cbed@cbed.com.br

30262633

Study Officials

• Doris Hexsel, MD

  Brazilian Center for Dermatologic Studies

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 19, 2012
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: July 26, 2019
• Results First Posted: August 11, 2014

Record last verified: 2019-07

Locations

BR (1)