BOTOX® Cosmetic and Skin Health.

A Randomized, Double Blind Evaluation of the Effects of BOTOX® Cosmetic on Skin Health

This is a two cohort, randomized, double blind, single center study to evaluate the effects of Botox Cosmetic (BTX) on sebum protection. Thirty-four female subjects with moderate-to-high skin sebum concentration will be recruited and randomized in a 1:1 ratio to treatment groups.

Study Overview

• Status: Completed
• Conditions: Oily Skin
• Intervention / Treatment: Drug: Botox Cosmetic

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3R 3A1
      • Erevna Innovations Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age above 18 years.
2. Female sex.
3. A SebumeterTM score >66ug/cm2 at Baseline.
4. Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study.
5. Signed and dated informed consent to participate in the study and unrestricted use of facial images for marketing purpose.
6. If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
7. Subject agrees to use the same topical cosmetic products (e.g., cleansers, moisturizers) throughout the duration of the trial, and at least for 30 days prior to enrolment.
8. Subject is on a stable diet and is not planning any major dietary changes throughout the duration of the trial.
9. Subject is not planning on undergoing any major hormonal changes throughout the duration of the study (e.g., menopause, change in medications).

Exclusion Criteria:

1. Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
2. Patients meeting any official BOTOX® Cosmetic contra-indications;
3. Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period;
4. Heavy smokers, classified as smoking more than 12 cigarettes per day;
5. History of severe or multiple allergies manifested by anaphylaxis;
6. Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
7. Previous treatment with neurotoxins in the area under assessment, within 6 months prior to enrolment;
8. Previous treatment with soft tissue fillers in the area under assessment, within 6 months prior to enrolment;
9. Subjects presenting with known allergy to BOTOX® Cosmetic.
10. Subjects presenting with porphyria.
11. Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment site.
12. History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment.
13. Subjects using immunosuppressants.
14. Subjects prescribed systematic or topical (in the area under assessment) antibiotics within 1 month of enrolment.
15. Tattoos, piercings or visible markings that in the treating investigator's opinion, may interfere with results or assessments.
16. Cancer or precancer in the treatment area, e.g. actinic keratosis.
17. Patients with a tendency to form hypertrophic scars or any other healing disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Subjects will receive BTX in the glabella and forehead regions, using a traditional injection technique commonly utilized in aesthetic medicine. The traditional injection technique will deposit the neurotoxin into the targeted muscles; with up to 24 units being injected into the forehead and 20 units in the glabella.	Drug: Botox Cosmetic; BOTOX® Cosmetic is approved and commercially available for use in Canada. BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe frown lines between the eyebrows, crow's feet lines, and forehead lines in adults.
Experimental: Group 2; Subjects will receive the traditional, deep injection technique, in addition to a superficial intradermal injection technique, which uses micro-aliquots of toxin. The superficial technique will deposit 0.1 units of toxin at 5mm intervals, at the level of the deep dermis.	Drug: Botox Cosmetic; BOTOX® Cosmetic is approved and commercially available for use in Canada. BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe frown lines between the eyebrows, crow's feet lines, and forehead lines in adults.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin quality assessment	Reduction in sebum	Baseline versus Week 4

Collaborators and Investigators

• Sponsor: Andreas Nikolis
• Investigators: Principal Investigator: Andreas Nikolis, Erevna Innovations Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): December 11, 2022

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 2020-ALG-BTX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No