| Eligibility |
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.
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