Status and phase
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About
The purpose of this study is to evaluate the irritation level of tazarotene foam after 21 days of exposure on the skin of healthy volunteers.
Full description
This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to evaluate the potential of tazarotene foam to induce cutaneous irritation using a 21 day cumulative irritation assay in healthy adult volunteers. Approximately 40 healthy male and female volunteer subjects aged 18 to 65 years will be enrolled. All subjects will be exposed to patches containing tazarotene foam, vehicle foam, sodium lauryl sulfate 0.5% (positive control), and distilled water (negative control). Each set of patches will be applied to the same randomized sites once daily for 21 days; patches will be removed after 24 ±1 hours and the patch sites will be evaluated for signs inflammatory skin responses (eg, erythema, edema, papules) and superficial effects.
Enrollment
Sex
Ages
Volunteers
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 .
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:
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
Primary purpose
Allocation
Interventional model
Masking
39 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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