Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses

NCT ID: NCT01732809

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-11-30

Brief Summary

The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activity.

Detailed Description

This is a prospective, single-center, randomized, double-blind study. All participants were recruited from a research center in Porto Alegre, Brazil, and provided written informed consent. The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activities. Nineteen patients were enrolled and evaluations were performed at baseline and 28 days after treatment.

Conditions

Skin Wrinkling

Keywords

wrinkles; botulinum toxin; abobotulinumtoxinA; onabotulinumtoxinA; field of anhydrotic effects

Study Design

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

Study Groups

abobotulinumtoxin A

Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received abobotulinumtoxin A in one of the sides of the forehead.

Group Type: ACTIVE_COMPARATOR

AbobotulinumtoxinA (ABO)

Intervention Type: DRUG

Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.

onabotulinumtoxin A

Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received onabotulinumtoxin A in one of the sides of the forehead.

Group Type: ACTIVE_COMPARATOR

OnabotulinumtoxinA (ONA)

Intervention Type: DRUG

Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.

Interventions

AbobotulinumtoxinA (ABO)

Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.

Intervention Type: DRUG

OnabotulinumtoxinA (ONA)

Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.

Intervention Type: DRUG

Other Intervention Names

Dysport®; Botox®

Eligibility Criteria

Inclusion Criteria

1. Signed consent

2. Female subjects aged between 18 to 60 years

3. Phototype I to IV

4. Moderate to severe wrinkles in the forehead region on maximal contracture of the frontalis muscle according to the Wrinkle Severity Scale

5. Subjects with the Minor Test* considered positive from grade 3 to 5 on the Minor test sweat intensity scale, showing sweat on the forehead under standardized conditions

6. Medical history and clinical examination that, in the investigator's opinion, do not prevent the subject from participating in the study or from using the proposed medication

7. Negative urinary pregnancy test at the initial visit for women of childbearing potential

8. Use of an effective contraceptive method (oral or injectable contraception, abstinence, intrauterine device, diaphragm, hysterectomy or bilateral ovariectomy, tubal attachment, condom, sponge, spermicide or partner with vasectomy) throughout the study for women of childbearing potential

1. Pregnancy or intention to become pregnant during the study period

2. Breastfeeding

3. Botulinum toxin treatments in the last 6 months

4. Subjects participating in other clinical studies

5. Any surgical procedure performed that has affected the frontal or orbicularis muscle, previous blepharoplasty or eyebrow raising

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

7. Fronto-parietal alopecia according to the Norwood-Hamilton classification

8. Neoplastic, muscular or neurological diseases

9. Use of using aminoglycoside antibiotics or penicillamines, quinine or calcium channel blockers or that they will use at any time during the study

10. Inflammatory or infectious processes at the application site

11. Evident facial asymmetry

12. History of adverse event, such as sensitivity to the components of the formula, ptosis or any other adverse event that, in the investigator's opinion, prevents the research subject from participating in the study

13. Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron disease

14. Coagulation disorders or use of anticoagulants

15. Autoimmune disease

16. History of poor adherence to treatments or who have shown lack of cooperation to adhere to the study protocol

17. Any condition that, in the investigator's opinion, could compromise the results 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

Doris Hexsel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doris M Hexsel, MD

Role: PRINCIPAL_INVESTIGATOR

Brazilian Center for Studies in Dermatology

Locations

Brazilian Center for Studies in Dermatology

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

Hexsel D, Hexsel C, Siega C, Schilling-Souza J, Rotta FT, Rodrigues TC. Fields of effects of 2 commercial preparations of botulinum toxin type A at equal labeled unit doses: a double-blind randomized trial. JAMA Dermatol. 2013 Dec;149(12):1386-91. doi: 10.1001/jamadermatol.2013.6440.

Reference Type: DERIVED

PMID: 24108521 (View on PubMed)

Other Identifiers

11-2011

Identifier Type: -

Identifier Source: org_study_id