Irritation Potential of Topic AgentPhase 1NCT03301870
A Study to Evaluate the Irritation Potential of ATx201 in Healthy Volunteers
A Phase 1 study testing ATx201 Gel 2% and ATx201 Gel 4% in people with Irritation Potential of Topic Agent, run by UNION therapeutics at 1 site in United States.
Trial summary
This is a Phase I single-site study to evaluate the irritation potential of topically applied ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201 GEL Placebo), in healthy human subjects on intact and abraded skin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritation Potential of Topic Agent
- What is being tested?
- ATx201 Gel 2% and ATx201 Gel 4%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2017to 6 Nov 2017
- 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
- Judged by the Investigator to have no health conditions that would impact the safety of the subject during participation.
- Body Mass Index (BMI) to be 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 a medically acceptable contraceptive method
- Willing to refrain from excessive consumption of sodium (> 2,400 mg/day or > 1 teaspoon equivalent/day) 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
- any clinical investigational product within 30 days prior to Day 1 through EOS Visit
- recent or current medical condition that, in the opinion of the Investigator, might significantly affect an immunological response to topical ATx201 or compromise the safety of the subject.
- 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.
- use of any medication on a regular basis within 14 days prior to Day 1 through EOS that could change peripheral blood flow, with the exception of any prescribed birth control method or hormone replacement therapy.
- use of any oral, nasal or topical corticosteroids, or oral or topical retinoids (other than Vitamin A at normal dietary amounts) within 14 days prior to the Screening Visit through EOS Visit.
- intending to start, stop, or change the dose of any prescription or over-the-counter (OTC) medication within 48 hours prior to Day 1 through EOS Visit.
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- use of any prescription or OTC topical medications on the upper back within 30 days prior to Day 1 through EOS Visit.
- history of sensitivity/allergy to any ingredients found in the ATx201 formulation or has a history of adverse reactions to topical medications.
- significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex.
- history of significant skin conditions or disorders such as psoriasis, atopic dermatitis, etc.
- history of significant dermatologic cancers, for example, melanoma or squamous cell carcinoma.
- displays an obvious difference in skin color on the upper back or the presence of a skin anomaly such as a recent sunburn, scratch, scar tissue, tattoo, or coloration that would interfere with placement of test sites, their assessment, and their potential response to the study drug or that could compromise the safety of the subject.
- smoking or use of tobacco or nicotine delivery products within 14 days prior to Day 1 through EOS Visit.
- female who is pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study.
- history of drug or alcohol addiction or abuse within the past year.
- caffeine intake greater than 500 mg per day (for example, 1 cup of coffee contains approximately 85 mg of caffeine, tea approximately 25 mg, soft drinks up to 115 mg, energy drinks 90 - 422 mg).
- unwilling to abstain from energy drinks, alcohol, and excessive caffeine (> 500 mg/day) for 48 hours prior to Day 1 through EOS Visit.
- reports having donated blood or plasma within 48 hours 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 Irritation Potential Of Topically Applied ATx201 In Healthy Human Volunteers on Intact and Abraded Skin
This is a Phase I single-site study to evaluate the irritation potential of topically applied ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201 GEL Placebo), in healthy human subjects on intact and abraded skin. Approximately thirty-six (36) healthy adult subjects will receive all the test articles to provide for 30 subjects to complete the study. The test articles will be applied to the upper back of the subjects during the study, and the placement of the test articles will be randomized. Abraded skin will be induced using sequential tape stripping.
- Conditions
- Irritation Potential of Topic Agent
- Being tested
- ATx201 Gel 2%, ATx201 Gel 4%, Positive Control, Negative Control, ATx201 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATx201 Gel 2%Drug
2% active gel
ATx201 Gel 4%Drug
4% active gel
Positive ControlDrug
Sodium Lauryl Sulfate 0.05% (w/v), USP in sterile, distilled Water for Injection, USP
Negative ControlDrug
Water for Injection, USP
ATx201 PlaceboDrug
matching placebo gel
| Study group | Role | What they receive |
|---|---|---|
| ATx201 GEL, 2% - intact skin | Experimental | ATx201 GEL, 2% applied intact skin Receives: Drug: ATx201 Gel 2% |
| ATx201 GEL, 4% - intact skin | Experimental | ATx201 GEL, 4% applied to intact skin Receives: Drug: ATx201 Gel 4% |
| ATx201 GEL, 2% - abraded skin | Experimental | ATx201 GEL, 2% applied to abraded skin Receives: Drug: ATx201 Gel 2% |
| ATx201 GEL, 4% - abraded skin | Experimental | ATx201 GEL, 4% applied to abraded skin Receives: Drug: ATx201 Gel 4% |
| ATx201 GEL Placebo - intact skin | Placebo comparator | ATx201 GEL Placebo applied to intact skin Receives: Drug: ATx201 Placebo |
| ATx201 GEL Placebo - abraded skin | Placebo comparator | ATx201 GEL Placebo applied to abraded skin Receives: Drug: ATx201 Placebo |
| Negative Irritant Control - intact skin | Active comparator | Negative (low) Irritant Control applied to intact skin Receives: Drug: Negative Control |
| Negative Irritant Control - abraded skin | Active comparator | Negative (low) Irritant Control applied to abraded skin Receives: Drug: Negative Control |
| Positive Irritant Control - intact skin | Active comparator | Positive (high) Irritant Control applied to intact skin Receives: Drug: Positive Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Irritation Scores
the sum of the combined Dermal response and Other Effects Score
Measured: 21 days
Secondary outcomes (3)
Time of combined Dermal response and Other Effects Score >=3
Total number of days with a combined Dermal Response and Other Effects score of 3 or more for each test article
Measured: 21 days
Incidence of Test Article Discontunation
Number of subjects, by test article, where a test article was discontinued due to an unacceptable degree of irritation, or who experienced symptomatic intolerable irritation
Measured: 21 days
Time to test article discontinuation
Number of days until sufficient irritation occurred to preclude repeat application to the same site, or who experienced symptomatic intolerable irritation
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 posted4 Oct 2017
- Study start4 Oct 2017
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritation Potential of Topic AgentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the assignment of the test articles to the test sites will be randomized. Each "arm" is a different patch of skin on the same study participant
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNION therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Prokocimer, MD, Study director, Sponsor CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301870
- Sponsor's protocol ID
- ATx201-006
- Status last verified
- Jan 2019
- First submitted
- 29 Sep 2017
- Last updated
- 16 Jan 2019
- 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 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Site Study To Evaluate The Irritation Potential Of Topically Applied ATx201 In Healthy Human Volunteers on Intact and Abraded Skin
- ClinicalTrials.gov ID
- NCT03301870
- Acronym / sponsor ID
- ATx201-006
- Conditions
- Irritation Potential of Topic Agent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- UNION therapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 4 Oct 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 irritation potential of topically applied ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201 GEL Placebo), in healthy human subjects on intact and abraded skin. Approximately thirty-six (36) healthy adult subjects will receive all the test articles to provide for 30 subjects to complete the study. The test articles will be applied to the upper back of the subjects during the study, and the placement of the test articles will be randomized. Abraded skin will be induced using sequential tape stripping.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 9
- Model description
- the assignment of the test articles to the test sites will be randomized. Each "arm" is a different patch of skin on the same study participant
| Arm | Type | Receives |
|---|---|---|
| ATx201 GEL, 2% - intact skin | Experimental | Drug: ATx201 Gel 2%ATx201 GEL, 2% applied intact skin |
| ATx201 GEL, 4% - intact skin | Experimental | Drug: ATx201 Gel 4%ATx201 GEL, 4% applied to intact skin |
| ATx201 GEL, 2% - abraded skin | Experimental | Drug: ATx201 Gel 2%ATx201 GEL, 2% applied to abraded skin |
| ATx201 GEL, 4% - abraded skin | Experimental | Drug: ATx201 Gel 4%ATx201 GEL, 4% applied to abraded skin |
| ATx201 GEL Placebo - intact skin | Placebo comparator | Drug: ATx201 PlaceboATx201 GEL Placebo applied to intact skin |
| ATx201 GEL Placebo - abraded skin | Placebo comparator | Drug: ATx201 PlaceboATx201 GEL Placebo applied to abraded skin |
| Negative Irritant Control - intact skin | Active comparator | Drug: Negative ControlNegative (low) Irritant Control applied to intact skin |
| Negative Irritant Control - abraded skin | Active comparator | Drug: Negative ControlNegative (low) Irritant Control applied to abraded skin |
| Positive Irritant Control - intact skin | Active comparator | Drug: Positive ControlPositive (high) Irritant Control applied to intact skin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Judged by the Investigator to have no health conditions that would impact the safety of the subject during participation.
- Body Mass Index (BMI) to be 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 a medically acceptable contraceptive method
- Willing to refrain from excessive consumption of sodium (> 2,400 mg/day or > 1 teaspoon equivalent/day) in food or beverage 48 hours prior to Day 1 through EOS Visit.
Key exclusion criteria (18 listed)
- any clinical investigational product within 30 days prior to Day 1 through EOS Visit
- recent or current medical condition that, in the opinion of the Investigator, might significantly affect an immunological response to topical ATx201 or compromise the safety of the subject.
- 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.
- use of any medication on a regular basis within 14 days prior to Day 1 through EOS that could change peripheral blood flow, with the exception of any prescribed birth control method or hormone replacement therapy.
- use of any oral, nasal or topical corticosteroids, or oral or topical retinoids (other than Vitamin A at normal dietary amounts) within 14 days prior to the Screening Visit through EOS Visit.
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 |
|---|---|---|
| ATx201 Gel 2%2% active gel | Drug | ATx201 GEL, 2% - abraded skin, ATx201 GEL, 2% - intact skin |
| ATx201 Gel 4%4% active gel | Drug | ATx201 GEL, 4% - abraded skin, ATx201 GEL, 4% - intact skin |
| Positive ControlSodium Lauryl Sulfate 0.05% (w/v), USP in sterile, distilled Water for Injection, USP | Drug | Positive Irritant Control - intact skin |
| Negative ControlWater for Injection, USP | Drug | Negative Irritant Control - abraded skin, Negative Irritant Control - intact skin |
| ATx201 Placebomatching placebo gel | Drug | ATx201 GEL Placebo - abraded skin, ATx201 GEL Placebo - intact skin |
Primary outcome
Cumulative Irritation Scores
Time frame: 21 days
the sum of the combined Dermal response and Other Effects Score
3 secondary outcomes
Time of combined Dermal response and Other Effects Score >=3
Time frame: 21 days
Incidence of Test Article Discontunation
Time frame: 21 days
Time to test article discontinuation
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 16 Jan 2019.
- Individual participant dataSharing planned: No
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
Sponsor 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 Gel 2% and ATx201 Gel 4% in people with Irritation Potential of Topic Agent, 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 18 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 16 Jan 2019. 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?
Cumulative Irritation Scores (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 16 Jan 2019.