Sensitivity, Contact
Conditions
Brief summary
This is a Phase I, single-site study to evaluate the sensitization potential of topically applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.
Interventions
DRUGATx201
two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms
DRUGATx201 Placebo Gel
two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms
Sponsors
UNION therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Good general health * Body Mass Index no less than 19.0 and no greater than 36.0 kg/m² (inclusive). * Demonstrates a Fitzpatrick skin score of I - IV * Female subjects must agree to use acceptable contraceptive methods from the Screening Visit through 90 days after the End of Study (EOS) Visit; or postmenopausal status with no menses for at least 1 year prior to the Screening Visit. * Willing to refrain from excessive consumption of sodium in food or beverage 48 hours prior to Day 1 through EOS Visit. * Willing to shower using the same non-medicated soap/cleansers, and abstain from excessive sun exposure (including tanning salons) from the Screening Visit through EOS Visit.
Exclusion criteria
* Reports a history of diabetes mellitus, clinically significant asthma (acceptable if no episode within 5 years prior to Day 1), or currently diagnosed with hypertension or circulatory disease. * Reports use of any oral, nasal or topical corticosteroids, or oral or topical retinoids (other than Vitamin A at normal dietary amounts) * Reports a significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex. * Reports a history of significant skin conditions or disorders such as psoriasis, atopic dermatitis, etc. * Reports a history of significant dermatologic cancers. * Displays an obvious difference in skin color between upper arms or upper back or the presence of a skin anomaly * Reports smoking or use of tobacco or nicotine delivery products within 14 days prior to Day 1 through EOS Visit. * Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator. * A female who is pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study. * Reports a history of drug or alcohol addiction or abuse within the past year. * Reports having donated blood or plasma within 48 hours prior to Day 1 through EOS Visit. * Subject exhibits excessive hair density on the upper arms or back such that patch adhesion could be compromised. * Subject reports undergoing hair depilation (e.g. chemical, laser, physical) within 30 days prior to Day 1 through EOS Visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermal Response Score | 21 days | number of patients with a dermal response score of at least 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermal Response and Effects Score | 21 days | number of patients with a dermal response and effects score of at least 3 |
Countries
United States
Outcome results
None listed