| Study summary: |
|
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing
tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742
subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio
(tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the
entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and
at weeks 2, 4, 8, and 12. |
| Criteria: |
|
Inclusion Criteria:
- Male or female age 12 through 45 years, inclusive, who is in good general health.
- An ISGA score of 3 or greater at baseline.
- Lesion counts meeting both of the following criteria:
1. Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular
lesion (<5mm), with NO cystic lesions.
2. Between 30 and 125 facial noninflammatory lesions, excluding nasal lesions.
- Regular menstrual cycle prior to study entry for females of childbearing potential.
- Negative urine pregnancy test for females of childbearing potential. • Sexually
active females of childbearing potential participating in the study must agree to use
a medically acceptable method of contraception while receiving protocol-assigned
product. A woman of childbearing potential is defined as one who is biologically
capable of becoming pregnant; including perimenopausal women who are less than 2
years from their last menses.
Women who are not currently sexually active must agree to use medically accepted method of
contraception should they become sexually active while participating in the study. Male
subjects and/or their partners must use a medically acceptable form of contraception.
- Capable of understanding and willing to provide signed and dated written voluntary
informed consent before any protocol specific procedures are performed.
- Ability and willingness to follow all study procedures, attend all scheduled visits,
and successfully complete the study.
Exclusion Criteria:
- Female who is pregnant, trying to become pregnant, or breast feeding.
- Use of topical antibiotics on the face within the past 2 weeks.
- Use of systemic antibiotics for acne treatment within the past 4 weeks.
- Concurrent use of medications known to be photosensitizers (eg, thiazides,
tetracyclines) because of the possibility of augmented photosensitivity.
- Use of topical corticosteroids on the face within the past 2 weeks or systemic
corticosteroids within the past 4 weeks.
- Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
- Treatment with estrogens, androgens, or anti-androgenic agents for 12 weeks or less
immediately prior to study enrollment. Subjects that have been treated with these
medications for more than 12 consecutive weeks prior to study enrollment are allowed
to enroll as long as they do not expect to change the dose or drug, or to discontinue
use during the study and it has not been indicated for the treatment of acne
vulgaris.
- Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, or
salicylates) within the past 2 weeks.
- Concomitant use of facial products such as: abradants, facials, peels containing
glycolic or other acids, masks, washes or soaps.
- Concomitant use of medications that are reported to exacerbate acne (eg, mega-doses
of certain vitamins, haloperidol, and immunosuppressants such as cyclosporine) as
these may impact efficacy assessments. Multivitamins, iron supplements, and folate
are acceptable.
- Facial procedure (eg, blue light, chemical or laser peel, or microdermabrasion)
within the past 4 weeks.
- Require or desire excessive or prolonged exposure to ultraviolet light during the
study.
- Known hypersensitivity or previous allergic reaction to any of the active components
of the study product.
- A significant medical history of or currently immunocompromised.
- Use of any investigational product within the past 4 weeks or currently participating
in another clinical study.
- Any other condition which, in the judgment of the investigator, would put the subject
at unacceptable risk for participation in the study.
- Any major illness within 30 days before study enrollment.
- Currently lives in the same household as currently enrolled subjects; is an employee
of Stiefel, an investigator, or a CRO involved in the study; or is an immediate
family member (eg, partner, offspring, parents) of an employee involved in the study |