Clinical trial NCT03375957: Sensitization Study of ATx201 in Healthy Volunteers
Official title: A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sensitivity, Contact
Lead sponsor: UNION therapeutics
Sponsor class: INDUSTRY
First posted: 2017-12-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dermal Response Score
timeFrame: 21 days
Secondary outcomes:
measure: Dermal Response and Effects Score
timeFrame: 21 days
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC
state: Missouri
Study officials:
affiliation: CMO
name: Philippe Prokocimer, MD
role: STUDY_DIRECTOR
References: