A Randomized, Double Blind Evaluation of the Effects of BOTOX® Cosmetic on Skin Health
Overview
- Phase
- Not Applicable
- Intervention
- Botox Cosmetic
- Conditions
- Oily Skin
- Sponsor
- Andreas Nikolis
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Skin quality assessment
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Andreas Nikolis
Medical Director
Erevna Innovations Inc.
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: Botox Cosmetic
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.
Intervention: Botox Cosmetic
Outcomes
Primary Outcomes
Skin quality assessment
Time Frame: Baseline versus Week 4
Reduction in sebum