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Do you suffer from red, irritated bumps concentrated on your forehead, cheeks, nose and chin? If so, you may be eligible to participate in a clinical study of an investigational medicine for those with facial acne. You must be 9 years old or older to participate in this trial.

FX2017-22 INCLUSION/EXCLUSION CRITERIA

 

INCLUSION CRITERIA

A male or female subject will be considered eligible for participation in the study if all of the following inclusion criteria are satisfied prior to randomization:

Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Subjects less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF.

Is 9 years of age or greater.
Has facial acne vulgaris with:

20 to 50 inflammatory lesions (papules, pustules, and nodules)
25 to 100 non-inflammatory lesions
(open and closed comedones)
No more than 2 nodules on the face
IGA score of moderate (3) to severe (4)

if a female of child-bearing potential, have a negative urine pregnancy test.

For women of child-bearing potential at risk of becoming pregnant, agree to an effective method of contraception.

Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.

APPLICATION INSTRUCTIONS

• Shake the canister well before use
• A small amount of foam (cherry-sized amount; ½ gram) should be expressed from the canister onto the fingertips
• Then applied and rubbed into all acne-affected parts of the face
• If acne is present on other parts of your body (neck, shoulders, arms, back, or chest), additional amounts (up to 4g) of foam
should be applied to those areas
• Apply at approximately the same time daily; preferably about 1 hour before bedtime
• DO NOT bathe, shower, or swim for at least 1 hour after application of the study drug.

EXCLUSION CRITERIA

Subjects who have any of the following will be excluded from the study:

Female who is pregnant or lactating, or is planning a pregnancy during the study.

Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.

Sunburn on the face.

Severe systemic disease that might interfere with the conduct of the study or the interpretation of the results.

Abnormal Screening laboratory values that are considered clinically significant.

Currently participating, or has participated within 30 days prior to this study, in an investigational drug or device study.

Inability to fully comply with the
study requirements.

Subjects who have a history of any of the following will be excluded:

Allergy to tetracycline-class antibiotics
or to any ingredient in the study drug

Pseudomembranous colitis or
antibiotic-associated colitis

Hepatitis or liver damage or renal impairment

Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers)

Subjects who have used the following medications (topical refers only to the facial area) will not be eligible:

Within 1 week prior to randomization:

Medicated facial cleansers
Topical acne treatments (other than those listed below)

Within 4 weeks prior to randomization:
Topical retinoids
Topical anti-inflammatories and corticosteroids
Systemic antibiotics

Systemic acne treatments
Within 12 weeks prior to randomization:
Systemic retinoids
Systemic corticosteroids

Drug addiction or alcohol abuse
(within the last 2 years).
Current or significant past history of depression.