Overview

A Study to Evaluate the Potential of Tazarotene Foam to Cause a Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers

Status:
Completed
Trial end date:
2010-04-10
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a phototoxic reaction when exposed to UV and VIS light on skin of healthy volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Stiefel, a GSK Company
Collaborator:
GlaxoSmithKline
Treatments:
Nicotinic Acids
Tazarotene
Criteria
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), or III (burns moderately; tans gradually) 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 Screening Visit 1.

- 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.

- A history of severe reactions from exposure to sunlight, including previous experience
with photoallergy, solar urticaria, polymorphous light eruptions, or other photo
exacerbated systemic diseases.

- Any major illness within 4 weeks of Screening Visit 1.

- 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.

- Used photosensitizing medications (prescription, nonprescription, or herbal) or a
known photosensitizing material within 2 weeks of Screening Visit 1.

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

- Received allergy injections within 1 week of Screening Visit 1, or expects to receive
allergy injections during study participation.

- Received immunizations within 4 weeks of Screening Visit 1.

- Used systemic or topical corticosteroids or other immunosuppressive medications within
4 weeks of Screening Visit 1.

- 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 Screening Visit 1.

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

- Used nonsteroidal anti inflammatory medications within 2 weeks of Screening Visit 1.

- 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.