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

Skin Wrinkling Clinical Trial

Official title:

Fields of Effects of Two Commercial Preparations of Botulinum Toxin Type A at Equal Labeled Unit Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732809
• Other study ID #: 11-2011
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2020
• Source: Brazilan Center for Studies in Dermatology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

9. Subjects must agree not to undergo other dermatological or aesthetic treatments during the study period *The Minor test must be the last test to be done. Only the subjects who fulfill all the inclusion criteria above undergo the Minor test to check for sweating in the frontal region. The graduation considered positive for inclusion in the study will be 3 to 5.

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Skin Wrinkling

Intervention

Drug:
• AbobotulinumtoxinA (ABO)
Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.
• OnabotulinumtoxinA (ONA)
Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.

Locations

Country	Name	City	State
Brazil	Brazilian Center for Studies in Dermatology	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Brazilan Center for Studies in Dermatology

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Horizontal Diameter of the Fields of Anhidrotic Effect	The Horizontal Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ); The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.; The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.	28 days
Primary	Vertical Diameter of the Fields of Anhidrotic Effect	The Vertical Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ); The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.; The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.	28 days
Primary	Area of the Fields of Anhidrotic Effect	The area of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ); The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.; The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.	28 days
Secondary	Wrinkle Severity Scale (WSS) at Maximum Contraction	It is a 4-point validated scale for forehead lines: 0 - None; - Mild; - Moderate; - Severe; The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.; Wrinkle scales are used to grade the muscular effects of botulinum toxin.; The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.	Baseline and 28 days
Secondary	Wrinkle Severity Scale (WSS) at Rest	It its a 4-point validated scale for forehead lines: 0 - None; - Mild; - Moderate; - Severe; The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.; Wrinkle scales are used to grade the muscular effects of botulinum toxin.; The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.	Baseline and 28 days
Secondary	Evoked Compound Muscle Action Potentials (ECMAP)	Amplitude of the evoked compound muscle action potentials in the frontalis muscle on stimulation of the facial nerve performed at baseline and visit 2 using surface electrodes on the forehead and electrical stimulation of the facial nerve according to standard neurophysiologic procedures.; The amplitude of the ECMAP was performed by an experienced neurologist using an electromyography device (Teca Sapphire; Teca Corp).	Baseline and 28 days