BOTOX® Cosmetic and Skin Health.

NCT ID: NCT05138835

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2022-12-11

Brief Summary

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.

Conditions

Oily Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Botox Cosmetic

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Botox Cosmetic

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Andreas Nikolis

OTHER

Sponsor Role: lead

Responsible Party

Andreas Nikolis

Medical Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andreas Nikolis

Role: PRINCIPAL_INVESTIGATOR

Erevna Innovations Inc.

Locations

Erevna Innovations Inc

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2020-ALG-BTX

Identifier Type: -

Identifier Source: org_study_id