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Phase 4 Completed N=19 Randomized Double-blind Other

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

Skin Wrinkling
Source: ClinicalTrials.gov NCT01732809 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Horizontal Diameter of the Fields of Anhidrotic Effect — 0.84; 1.24 centimeters
◆ Published Evidence
Established
36citations · ~3 / year
Fields of effects of 2 commercial preparations of botulinum toxin type A at equal labeled unit doses: a double-blind randomized trial.
JAMA dermatology · 2013 · Likely link

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.

Linked Publications

  • Fields of effects of 2 commercial preparations of botulinum toxin type A at equal labeled unit doses: a double-blind randomized trial.
    JAMA dermatology · 2013 · 36 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Horizontal Diameter of the Fields of Anhidrotic Effect
0.84; 1.24
PRIMARY
Vertical Diameter of the Fields of Anhidrotic Effect
1.19; 1.50
PRIMARY
Area of the Fields of Anhidrotic Effect
0.86; 1.49
SECONDARY
Wrinkle Severity Scale (WSS) at Maximum Contraction
0; 0; 0; 0; 7; 6
SECONDARY
Wrinkle Severity Scale (WSS) at Rest
1; 1; 8; 7; 4; 5
SECONDARY
Evoked Compound Muscle Action Potentials (ECMAP)
1108.17; 1079.11; 202.89; 165.39

Eligibility Criteria

Inclusion Criteria

  • Signed consent
  • Female subjects aged between 18 to 60 years
  • Phototype I to IV
  • Moderate to severe wrinkles in the forehead region on maximal contracture of the frontalis muscle according to the Wrinkle Severity Scale
  • 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
  • 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
  • Negative urinary pregnancy test at the initial visit for women of childbearing potential
  • 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
  • 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

  • Pregnancy or intention to become pregnant during the study period
  • Breastfeeding
  • Botulinum toxin treatments in the last 6 months
  • Subjects participating in other clinical studies
  • Any surgical procedure performed that has affected the frontal or orbicularis muscle, previous blepharoplasty or eyebrow raising
  • Any cosmetic procedures, including fillers, or scars that may interfere with the results of the study
  • Fronto-parietal alopecia according to the Norwood-Hamilton classification
  • Neoplastic, muscular or neurological diseases
  • Use of using aminoglycoside antibiotics or penicillamines, quinine or calcium channel blockers or that they will use at any time during the study
  • Inflammatory or infectious processes at the application site
  • Evident facial asymmetry
  • 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
  • Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron disease
  • Coagulation disorders or use of anticoagulants
  • Autoimmune disease
  • History of poor adherence to treatments or who have shown lack of cooperation to adhere to the study protocol
  • Any condition that, in the investigator's opinion, could compromise the results of the study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01732809) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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