Sensitivity, Contact Clinical Trial
Official title:
A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers
Verified date | May 2018 |
Source | AntibioTx A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 240 |
Est. completion date | March 15, 2018 |
Est. primary completion date | February 17, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Bio-Kinetic Clinical Applications, LLC | Springfield | Missouri |
Lead Sponsor | Collaborator |
---|---|
AntibioTx A/S |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dermal Response Score | number of patients with a dermal response score of at least 2 | 21 days | |
Secondary | Dermal Response and Effects Score | number of patients with a dermal response and effects score of at least 3 | 21 days |
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