BOTOX Cosmetic and Skin Health.

  • STATUS
    Recruiting
  • End date
    Dec 11, 2022
  • participants needed
    34
  • sponsor
    Andreas Nikolis
Updated on 10 December 2021
Accepts healthy volunteers

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.

Details
Condition Oily Skin
Treatment Botox Cosmetic
Clinical Study IdentifierNCT05138835
SponsorAndreas Nikolis
Last Modified on10 December 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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