Comparison of Two Commercial Preparations of Botulinum Toxin Type A

NCT ID: NCT00959907

Last Updated: 2009-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-12-31

Brief Summary

The objective of this study is to compare the action halos of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.

Detailed Description

This was a monocentric, prospective, randomized and double-blind study. Fifty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. There were two randomizations, one related to the dose-equivalence (2:1U and 2.5:1U), both reconstituted in the same volume of 0.02 mL per point and another related to the forehead side (left or right) for application of the tested drugs. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.

Conditions

Wrinkles in Frontal Area

Keywords

Muscular activity; wrinkles in frontal area; action halos

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BoNT A1 (4U)

BoNT A1 (4U): Botulinum toxin A (Dysport®)4 units

Group Type: ACTIVE_COMPARATOR

BOTULINUM TOXIN TYPE-A

Intervention Type: DRUG

On Visit 1 (Day 0):

Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.

• Dysport®: 4 units will be injected in the left or right forehead side.
• Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)

BoNT-A2 (2U)

BoNT-A2(2U): Botulinum toxin A (Botox®) 2 units

Group Type: ACTIVE_COMPARATOR

BOTULINUM TOXIN TYPE-A

Intervention Type: DRUG

On Visit 1 (Day 0):

Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.

• Dysport®: 4 units will be injected in the left or right forehead side.
• Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)

Interventions

BOTULINUM TOXIN TYPE-A

On Visit 1 (Day 0):

Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.

• Dysport®: 4 units will be injected in the left or right forehead side.
• Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)

Intervention Type: DRUG

Other Intervention Names

BoNT A1 = Dysport; BoNT A2 = Botox

Eligibility Criteria

Inclusion Criteria

1. Written Informed Consent (Annex 1)

2. Female

3. Subjects agreeing to take part in all procedures of the study, including botulinum toxin applications, Minor's test, measurement of Evoked Potentials, photographs, etc.), after being fully informed on the objectives and nature of the investigations

4. Subjects aged between 18 and 60 years

5. Subjects presenting with moderate to severe wrinkles on the forehead under maximum voluntary contraction of the m. frontalis

6. Subjects with positive Minor's test showing sweating on the forehead in standardized conditions described in Annex 2

7. 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 products under investigation

8. Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using an effective contraceptive method;

9. Availability of the patient throughout the duration of the study (112 days)

10. Subject agrees not to undergo other cosmetic or dermatological procedures during the study

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

Exclusion Criteria

1. Pregnant women or women intending to become pregnant in the next 4 months after screening for eligibility

2. Subjects who are lactating

3. Subjects having undergone botulinum toxin treatment within the last 6 months

4. Subjects participating in other clinical trials

5. Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharoplasty or brow lift

6. Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results

7. Subjects presenting fronto-parietal alopecia according to the Norwood-Hamilton classification

8. Subjects with neoplastic, muscular or neurological diseases

9. Subjects using aminoglycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers

10. Subjects with inflammation or active infection in the area to be injected

11. Subjects presenting evident facial asymmetry

12. Subjects with a history of adverse effects, such as sensitivity to the components of the formula, ptosis or any other adverse effect, which in the investigator's opinion should prevent the patient from participating in the study

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

14. Subjects with coagulation disorders or using anticoagulants

15. Subjects with known systemic autoimmune diseases

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

17. Any condition that, in the opinion of the investigator, can compromise the evaluation of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brazilan Center for Studies in Dermatology

OTHER

Sponsor Role: lead

Responsible Party

CBED

Principal Investigators

Doris Hexsel, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Brazilian Center for Dermatological Studies

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

01-CBED06

Identifier Type: -

Identifier Source: org_study_id