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OpenTrials
Completed

NCT Number: NCT05138835

BOTOX® Cosmetic and 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erevna Innovations Inc

Montreal, Quebec, H3R 3A1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 18 years.
  • Female sex.
  • A SebumeterTM score >66ug/cm2 at Baseline.
  • 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.
  • Signed and dated informed consent to participate in the study and unrestricted use of facial images for marketing purpose.
  • If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
  • 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.
  • Subject is on a stable diet and is not planning any major dietary changes throughout the duration of the trial.
  • Subject is not planning on undergoing any major hormonal changes throughout the duration of the study (e.g., menopause, change in medications).

Exclusion criteria

  • 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)];
  • Patients meeting any official BOTOX® Cosmetic contra-indications;
  • Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period;
  • Heavy smokers, classified as smoking more than 12 cigarettes per day;
  • History of severe or multiple allergies manifested by anaphylaxis;
  • 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;
  • Previous treatment with neurotoxins in the area under assessment, within 6 months prior to enrolment;
  • Previous treatment with soft tissue fillers in the area under assessment, within 6 months prior to enrolment;
  • Subjects presenting with known allergy to BOTOX® Cosmetic.
  • Subjects presenting with porphyria.
  • Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment site.
  • 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.
  • Subjects using immunosuppressants.
  • Subjects prescribed systematic or topical (in the area under assessment) antibiotics within 1 month of enrolment.
  • Tattoos, piercings or visible markings that in the treating investigator's opinion, may interfere with results or assessments.
  • Cancer or precancer in the treatment area, e.g. actinic keratosis.
  • Patients with a tendency to form hypertrophic scars or any other healing disorders.

Treatment and study plan

Botox Cosmetic

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.

Primary outcomes

  1. Skin quality assessment

    Time frame: Baseline versus Week 4

    Reduction in sebum

Sponsors and collaborators

Lead sponsor

Andreas Nikolis

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2021
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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