Sensitivity, ContactPhase 1NCT03375957
Sensitization Study of ATx201 in Healthy Volunteers
A Phase 1 study testing ATx201 in people with Sensitivity, Contact, run by UNION therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity, Contact
- What is being tested?
- ATx201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 15 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, 65802
About this study
Official title: A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers
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.
- Conditions
- Sensitivity, Contact
- Being tested
- ATx201, ATx201 Placebo Gel
- Medical subject headings
- Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATx201Drug
two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms
ATx201 Placebo GelDrug
two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms
| Study group | Role | What they receive |
|---|---|---|
| ATx201 2% Gel | Experimental | Not described Receives: Drug: ATx201 |
| ATx201 4% Gel | Experimental | Not described Receives: Drug: ATx201 |
| ATx201 Gel Placebo | Placebo comparator | Not described Receives: Drug: ATx201 Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal Response Score
number of patients with a dermal response score of at least 2
Measured: 21 days
Secondary outcomes (1)
Dermal Response and Effects Score
number of patients with a dermal response and effects score of at least 3
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start8 Jan 2018
- Primary completion17 Feb 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitivity, ContactStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNION therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Prokocimer, MD, Study director, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375957
- Sponsor's protocol ID
- ATx201-005
- Status last verified
- May 2018
- First submitted
- 12 Dec 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT03375957
- Acronym / sponsor ID
- ATx201-005
- Conditions
- Sensitivity, Contact
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- UNION therapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 17 Feb 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ATx201 2% Gel | Experimental | Drug: ATx201 |
| ATx201 4% Gel | Experimental | Drug: ATx201 |
| ATx201 Gel Placebo | Placebo comparator | Drug: ATx201 Placebo Gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATx201two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms | Drug | ATx201 2% Gel, ATx201 4% Gel |
| ATx201 Placebo Geltwo hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms | Drug | ATx201 Gel Placebo |
Primary outcome
Dermal Response Score
Time frame: 21 days
number of patients with a dermal response score of at least 2
1 secondary outcome
Dermal Response and Effects Score
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Prokocimer, MD study director
CMO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATx201 in people with Sensitivity, Contact, run by UNION therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal Response Score (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.