RBR-9xmfyq
Completed
N/A
Evaluation of different doses of botulinum toxin type A for the treatment of gingival smile
Centro Brasileiro de Estudos em Dermatologia0 sitesJuly 1, 2020
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gingival smile
- Sponsor
- Centro Brasileiro de Estudos em Dermatologia
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Individuals aged between 18 and 70 years;
- •Superior anterior gingival exposure: more than 4 mm, for subjects included in group A and 2 to 4 mm, for subjects included in group B;
- •Presence of at least one indication for cosmetic treatment with botulinum toxin in the upper face;
- •Medical history and physical examination that, in the opinion of the investigator, does not interfere with the progress of the study;
- •Women of childbearing potential should have a negative urinary pregnancy test at visit 1\. These subjects should use a highly effective contraception method during the study: combined oral contraceptives \[estrogen and progesterone] or implanted contraceptives (with a stable dose for at least 1 month prior to study entry), bilateral tubal ligation, hormonal intrauterine device (inserted at least 1 month prior to study entry), strict abstinence (at least 1 month prior to entry into the study and agree to continue for the duration of the study), or vasectomized partner (at least 3 months prior to study entry) or use of condom;
- •Women presenting for childbearing potential (e.g. before menstruation, post menopause (absence of menstrual bleeding for 1 year before entry into the study), hysterectomy, or bilateral ovariectomy, less than one year postmenopausal);
- •Willingness to comply with protocol requirements and study duration.
- •Understanding and signing the Informed Consent Term (ICF) at baseline, before any study procedure is performed.
Exclusion Criteria
- •Pregnant and/or breastfeeding women, or women who wish to become pregnant during the study period;
- •Any surgical intervention that has affected the area evaluated in this study;
- •Any cosmetic procedures, including fillers, or scars that may interfere with the results of the study;
- •Previous treatment with botulinum toxin for gingival smile less than 6 months ago, or for other indications on the face less than 12 months ago;
- •Evident facial asymmetry;
- •Active inflammation or infections in the treated areas;
- •Neoplastic, muscle or neurological diseases (e.g. Myasthenia Gravis, Lambert\-Eaton Myasthenic Syndrome and motor neuron disease);
- •Serious psychiatric disorders;
- •Any other disease or chronic or serious decompensated medical condition that, in the opinion of the investigator, may interfere with the assessments or participation in the study or put subject at significant risk;
- •History of sensitivity to the formula components;
Outcomes
Primary Outcomes
Not specified
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