A Study To Evaluate The Contact Sensitization Potential Of Tazarotene Foam On Skin In Healthy Volunteers

This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to
evaluate the potential of tazarotene foam 0.1% to induce contact sensitization following
repeated exposure under maximal stress conditions in healthy adult volunteers. Approximately
240 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.

All subjects will be exposed to patches containing tazarotene foam and vehicle foam.
Inflammatory skin responses (eg, erythema, edema, papules) or superficial effects at patch
sites will be visually assessed and scored according to the corresponding grading scales.

The study duration will be 6 weeks or 9 weeks and will consist of the following phases: 3
week Induction, 2 week Rest, and 1 week Challenge, and if indicated, a second 2 week Rest
and 1 week Repeat Challenge.

Inclusion Criteria:

- Capable of understanding and willing to provide signed and dated written voluntary
informed consent and Health Information Portability and Accountability Act (HIPAA)
authorization before any protocol-specific procedures are performed.

- Male or female aged 18 to 65 years, inclusive, at time of consent.

- Able and willing to complete the study and to comply with all study instructions.

- Possess Fitzpatrick skin types I (always burns easily; never tans), II (always burns
easily; tans minimally), III (burns moderately; tans gradually), or IV (rarely burns;
tans with ease) that will not interfere with the evaluation of any skin responses
(Fitzpatrick 1988). Determination of skin types will be based on sunburn and tanning
histories, as well as subjects' opinions of their responses to the first 30 to 45
minutes of sun exposure.

- Male subjects and their partners must agree to use a medically acceptable method of
contraception.

Additional criteria for women of childbearing potential, defined as one who is
biologically capable of becoming pregnant, including perimenopausal women who are less
than 2 years from their last menses:

- A regular menstrual cycle before study entry (as reported by the subject).

- Negative urine pregnancy test within 2 weeks of the first application of study
product.

- Sexually active females of childbearing potential participating in the study must
agree to use a medically acceptable method of contraception throughout the duration
of the study. Acceptable contraceptive methods include the following:

- Hormonal contraception, including oral, injectable, or implantable methods
started at least 2 months prior to screening. If hormonal contraception was
started less than 2 months prior to screening, then a form of nonhormonal
contraception should be added until the third continuous month of hormonal
contraception has been completed.

- Two forms of reliable nonhormonal contraception, to include the use of either an
intrauterine device plus a reliable barrier method or 2 reliable barrier
methods. Reliable barrier methods include condoms or diaphragms. A cervical cap
is also a reliable barrier method, provided that the female subject has never
given birth vaginally. The combined use of a condom and spermicide constitute 2
forms of acceptable nonhormonal contraception, provided that they are both used
properly. The use of spermicide alone and the improper use of condoms are
inferior methods of contraception. Subjects with surgical sterilization,
including tubal sterilization or partner's vasectomy, must use a form of
nonhormonal contraception. A barrier method or sterilization plus spermicide is
acceptable.

Women who are not currently sexually active must agree to use a medically acceptable
method of contraception should they become sexually active while participating in the
study.

Exclusion Criteria:

- Female who is pregnant, trying to become pregnant, or breast feeding.

- Considered unable or unlikely to attend the necessary visits.

- History of known or suspected intolerance to tazarotene, any of the ingredients of
the study products, the hypoallergenic tape, or the cotton patches.

- Participation in any patch test study within 4 weeks of the Day 1 visit.

- Inability to evaluate the skin in and around the potential patch test sites on the
back due to sunburns, unevenness in skin tones, tattoos, scars, excessive hair,
freckles, birthmarks, moles, or other skin damage or abnormality.

- Clinically significant skin diseases that may contraindicate participation or
interfere with patch test site evaluations, including psoriasis, eczema, atopic
dermatitis, acne, dysplastic nevi, or other skin pathologies, or a history of skin
cancer.

- Any major illness within 4 weeks of the Day 1 visit.

- Considered immunocompromised.

- A clinically relevant history of or current evidence of abuse of alcohol or other
drugs.

- Clinically relevant history or currently suffering from any disease or condition
that, in the opinion of the investigator, may affect the evaluation of the study
product or place the subject at undue risk. This may include respiratory (including
chronic asthma requiring repetitive drug interventions), gastrointestinal, renal,
hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric,
musculoskeletal, genitourinary, immunological, dermatological, or connective tissue
diseases or disorders.

- Received any investigational product or procedure within 4 weeks of the Day 1 visit
or who is scheduled to receive an investigational product (other than the study
product) or procedure during the study.

- Received allergy injections within 1 week of the Day 1 visit, or expects to receive
allergy injections during study participation.

- Received immunizations within 4 weeks of the Day 1 visit.

- Used systemic or topical corticosteroids or other immunosuppressive medications
within 4 weeks of the Day 1 visit.

- Used topical medications or other products (eg, self tanning products, waxing
products, benzoyl peroxide, salicylic acid, or sulfur) in the areas of patch testing
within 2 weeks of the Day 1 visit.

- Used antihistamines, selective leukotriene receptor antagonists (eg, montelukast
sodium, zafirlukast), or mast cell stabilizers (eg, cromolyn sodium or nedocromil
sodium) within 4 weeks of the Day 1 visit.

- Used nonsteroidal anti-inflammatory medications within 2 weeks of the Day 1 visit.

- Currently using any medication that, in the opinion of the investigator, may affect
the evaluation of the study product or place the subject at undue risk.

- Participated in a previous study of the same study product.

- Employee of the study center, contract research organization, or Stiefel who is
involved in the study, or an immediate family member (eg, partner, offspring,
parents, siblings or sibling's offspring) of an employee who is involved in the
study.