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Use of Oracea and Epiduo Forte in patients with severe acne

Inclusion criteria:

I. Ambulatory male or female volunteers of any race and at least 12 years old. Female subjects of childbearing potential must have a negative urine pregnancy test result at the start of the study (test must have a sensitivity of at least 25 milli-international units / milliliter [mIU / ml] for human chorionic gonadotropin) and practice a reliable method of contraception during the study:

A woman is considered childbearing unless she is:

- at least 12 months after menopause before the administration of the drug;

- without a uterus and / or both ovaries; or

- Was surgically sterile for at least 6 months prior to drug administration

Reliable contraception methods are:

- Hormonal methods or intrauterine devices used ≥ 90 days prior to the drug test Administration;

- Barrier methods plus spermicide applied at least 14 days before the drug is administered; or

- vasectomized partner (the vasectomy must be performed 3 months before the first study drug administration or alternatively a sperm count of zero will be sufficient) [exception: female subjects of childbearing age who are not sexually active will not be required to use a reliable method of contraception to practice. These subjects may be enrolled at the investigator's discretion if they are advised to remain sexually inactive during the study and understand the potential risks of pregnancy during the study.] Ii. IGA score for facial acne of 4 iii. At least 20 or more inflammatory lesions and 20 or more non-inflammatory lesions and no more than 4 nodules iv. Able to understand the study requirements and sign Informed Consent / HIPAA authorization forms. Individuals below the legal age of consent in the state where the study conducted must also have written, informed consent from a parent or legal entity

Exclusion criteria:

I. Female subjects who are pregnant (positive urine pregnancy test), breastfeeding or persons of childbearing potential who do not use reliable methods of contraception ii. Allergy or sensitivity to any component of the test drug iii. Issues that do not have proper washout times for Prohibited Drugs (Supplement I)> iv. Disease which, in the investigator's opinion, contraindicated the patient's participation in the clinical study v. Skin disease / disorder that affects the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse vii. A history of poor collaboration, non-compliance with medical treatment, or unreliability viii. Exposure to an investigational medicinal product study within 30 days of the baseline visit -