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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01732809
Other study ID # 11-2011
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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