Botulinum Toxin type A for the treatment of smile with gum exposure

Not Applicable

• Conditions: Gingival smile; A14.549.167.646.480

• Registration Number: RBR-9xmfyq
• Lead Sponsor: Centro Brasileiro de Estudos em Dermatologia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

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;
Current use of aminoglycoside antibiotics or penicillamines, quinines or calcium channel blockers or use at any time during the study;
Coagulation disorders or use of anticoagulants;
Vulnerable subjects (such as those deprived of their liberty) as defined in Section 1.61 of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for Good Clinical Practice (GCP);
Subjects with history of non-adherence to medications or showing difficulties to adhere to the study protocol;
Current participation in another drug or device clinical study OR participation within 30 days prior to Day 1 OR in a period of exclusion from a previous clinical study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified