Impact of Botox Treatment Into the Upper One Third of the Face an Area on Mood and Self -Appearance Satisfaction

NCT04439825 | Completed Phase 1 FDA Drug

• 1 other identifier: BTX-PST-COVID
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Botox treatment into the upper one third of the face (glabella, forehead lines and/or lateral canthal lines) to analyze mood and self -appearance satisfaction in a Post Covid period on non-naïve Botox patients

Conditions

Mood

Outcome Measures

Primary Outcomes (2)

• Self- perception of mood before treatment and after achieving an optimal cosmetic result as determined by the PI.

  Treatment with Botox into the glabellar furrows increase the self- satisfaction with appearance once optimal correction is achieved beyond baseline in non -naïve users as compared to a control group and to themselves.

  1 month

• Happiness levels before treatment and after achieving an optimal cosmetic result as determined by the PI.

  Treatment with Botox into the glabellar furrows increase the happiness levels once optimal correction is achieved beyond baseline in non -naïve users as compared to a control group and to themselves.

  1 month

Secondary Outcomes (1)

• Measurement of the Glabellar Wrinkle Severity Scores before treatment. The onset of effect and maximum efficacy compared to previous BOTOX Cosmetic injections will also be assessed by questionnaires.

  1 month

Study Arms (2)

Botox

ACTIVE COMPARATOR

Drug: Botulinum Neurotoxin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Botulinum Neurotoxin DRUG

glabella, forehead lines and/or lateral canthal lines

Botox

Placebo DRUG

Saline solution (preservative free)

Placebo

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between the ages of 18-75
• Subjects will be non-naive Botox users with a glabellar wrinkle severity score of 2 or 3 who are at least 20 weeks from their last BOTOX Cosmetic treatment
• Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visits.

You may not qualify if:

• Males and females below the age of 18
• Subjects that received neuromodulator injections to the glabella region in the last 20 weeks
• Subjects who do not meet a 2-3 wrinkle severity score in the glabellar region
• Subjects who have received other invasive or semi invasive cosmetic forehead or glabellar treatments
• Subjects who have had a change in antidepressant or anti- anxiety medication in last 6 weeks
• Subjects with severe depression, bipolar disorder, pregnant,
• Subjects who are pregnant, attempting to get pregnant, or breast feeding
• Subjects with a known allergy or sensitivity to any component of the study ingredients.
• Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.

Sponsors & Collaborators

• DeNova Research: lead

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Dayan SH. Mind, Mood, and Aesthetics. Aesthet Surg J. 2015 Aug;35(6):759-61. doi: 10.1093/asj/sjv032. Epub 2015 Jun 4. No abstract available.

  PMID: 26044342 RESULT

MeSH Terms

Interventions

Botulinum Toxins

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 19, 2020
• Study Start: July 20, 2020
• Primary Completion: September 3, 2020
• Study Completion: December 1, 2020
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)