Clinical trial NCT01732809: Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses
Official title: Fields of Effects of Two Commercial Preparations of Botulinum Toxin Type A at Equal Labeled Unit Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Wrinkling
Keywords: wrinkles
botulinum toxin
abobotulinumtoxinA
onabotulinumtoxinA
field of anhydrotic effects
Lead sponsor: Brazilan Center for Studies in Dermatology
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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
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

Primary outcomes:
measure: Horizontal Diameter of the Fields of Anhidrotic Effect
timeFrame: 28 days
measure: Vertical Diameter of the Fields of Anhidrotic Effect
timeFrame: 28 days
measure: Area of the Fields of Anhidrotic Effect
timeFrame: 28 days
Secondary outcomes:
measure: Wrinkle Severity Scale (WSS) at Maximum Contraction
timeFrame: Baseline and 28 days
measure: Wrinkle Severity Scale (WSS) at Rest
timeFrame: Baseline and 28 days
measure: Evoked Compound Muscle Action Potentials (ECMAP)
timeFrame: Baseline and 28 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Brazilian Center for Studies in Dermatology
state: RS
Study officials:
affiliation: Brazilian Center for Studies in Dermatology
name: Doris M Hexsel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.