Atopic DermatitisPhase 2NCT03304470
A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis
A Phase 2 study testing ATx201 2% Cream in people with Atopic Dermatitis, run by UNION therapeutics at 1 site in Canada.
Trial summary
This is a Phase 2, 3-week, single-center, double-blind, randomized, two-arm, vehicle controlled study, with each individual receiving both active and vehicle treatment. Approximately 30 subjects with moderate atopic dermatitis will receive topically applied ATx201 CREAM 2% and matching vehicle once daily for 3 weeks… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ATx201 2% Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2017to 5 Mar 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically confirmed diagnosis of active atopic dermatitis
- at least a 6-month history of atopic dermatitis and had no significant flares in atopic dermatitis for at least 4 weeks before screening
- ≥2 areas of atopic dermatitis (excluding face, scalp, genitals, hands, and feet) of at least 3 × 3 cm; with a lesional TSS of ≥5 at Day 1 for each treatment area
Who cannot join
- breastfeeding, pregnant, or is planning to become pregnant during the study.
- clinically infected atopic dermatitis
- Fitzpatrick's Skin Phototype ≥5
- Presence of any tattoos, scratches, open sores, excessive hair, or skin damages in the target lesion areas
- known to have immune deficiency or is immunocompromised.
- history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
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- major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- clinically significant medical condition or physical/laboratory/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
- known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
- used hydroxyzine or diphenhydramine within 1 week prior to Day 1.
- used dupilumab within 12 weeks prior to Day 1.
- received any nonbiological investigational product or device within 4 weeks prior to Day 1
- used crisaborole and any other topical PDE-4 inhibitor within 4 weeks prior to Day 1.
- used doxepin within 1 week prior to Day 1.
- used topical products containing urea within 1 week prior to Day 1.
- used nonurea-containing emollient anywhere on the body from 1 day before Day 1.
- used systemic antibiotics or topical antibiotics on the treated areas within 2 weeks prior to Day 1.
- used any topical medicated treatment for atopic dermatitis within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials, medical devices, and bleach baths.
- used systemic treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to Day 1 (e.g., retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine, oral/injectable corticosteroids).
- received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
- excessive sun exposure, is planning a trip to a sunny climate, has received ultraviolet phototherapy, or has used tanning booths within 4 weeks prior to Day 1, or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products (excluding the treatment areas) and protective apparel are recommended when exposure cannot be avoided.
- known or suspected allergy to ATx201 or any component of the investigational product.
- known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
- history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
- history of hypertrophic scarring or keloid formation in scars or suture sites.
- taking anticoagulant medication, such as heparin, low molecular weight-heparin, warfarin, or antiplatelets (nonsteroidal anti-inflammatory drugs and aspirin ≤81 mg will not be considered antiplatelets) within 2 weeks prior to Day 1, or has a contraindication to skin biopsies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Intraindividual, Vehicle-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Topically Applied ATx201 in Subjects With Moderate Atopic Dermatitis
This is a Phase 2, 3-week, single-center, double-blind, randomized, two-arm, vehicle controlled study, with each individual receiving both active and vehicle treatment. Approximately 30 subjects with moderate atopic dermatitis will receive topically applied ATx201 CREAM 2% and matching vehicle once daily for 3 weeks (5 mg/cm2/day), without occlusion. ATx201 and vehicle will be applied on two separate target lesions of moderate atopic dermatitis (lesions of at least 3 × 3 cm, excluding the face, scalp, genitals, hands, and feet, ideally from the same anatomical location).
- Conditions
- Atopic Dermatitis
- Being tested
- ATx201 2% Cream, ATx201 Cream Vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATx201 2% CreamDrug
Anhydrous Cream
ATx201 Cream VehicleDrug
Anhydrous Cream
| Study group | Role | What they receive |
|---|---|---|
| ATx201 2% CREAM | Experimental | Not described Receives: Drug: ATx201 2% Cream |
| ATx201 Cream Vehicle | Placebo comparator | Not described Receives: Drug: ATx201 Cream Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local and systemic treatment-emergent adverse events
# of TEAEs
Measured: 34 days
Secondary outcomes (3)
Change from baseline in lesional Total Sign Score at Days 8, 15, and 22.
Measured: 22 Days
Change from baseline in lesional Treatment Areas Assessment at Days 8, 15, and 22
Measured: 22 Days
Change from baseline in skin barrier and biomarker levels at Day 22
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start25 Sep 2017
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNION therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Prokocimer, Study director, Sponsor CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304470
- Sponsor's protocol ID
- ATx201-003
- Status last verified
- Mar 2018
- First submitted
- 25 Sep 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Intraindividual, Vehicle-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Topically Applied ATx201 in Subjects With Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03304470
- Acronym / sponsor ID
- ATx201-003
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- UNION therapeuticsIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 9 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 2, 3-week, single-center, double-blind, randomized, two-arm, vehicle controlled study, with each individual receiving both active and vehicle treatment. Approximately 30 subjects with moderate atopic dermatitis will receive topically applied ATx201 CREAM 2% and matching vehicle once daily for 3 weeks (5 mg/cm2/day), without occlusion. ATx201 and vehicle will be applied on two separate target lesions of moderate atopic dermatitis (lesions of at least 3 × 3 cm, excluding the face, scalp, genitals, hands, and feet, ideally from the same anatomical location).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATx201 2% CREAM | Experimental | Drug: ATx201 2% Cream |
| ATx201 Cream Vehicle | Placebo comparator | Drug: ATx201 Cream Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinically confirmed diagnosis of active atopic dermatitis
- at least a 6-month history of atopic dermatitis and had no significant flares in atopic dermatitis for at least 4 weeks before screening
- ≥2 areas of atopic dermatitis (excluding face, scalp, genitals, hands, and feet) of at least 3 × 3 cm; with a lesional TSS of ≥5 at Day 1 for each treatment area
Key exclusion criteria (26 listed)
- breastfeeding, pregnant, or is planning to become pregnant during the study.
- clinically infected atopic dermatitis
- Fitzpatrick's Skin Phototype ≥5
- Presence of any tattoos, scratches, open sores, excessive hair, or skin damages in the target lesion areas
- known to have immune deficiency or is immunocompromised.
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 2% CreamAnhydrous Cream | Drug | ATx201 2% CREAM |
| ATx201 Cream VehicleAnhydrous Cream | Drug | ATx201 Cream Vehicle |
Primary outcome
Incidence of local and systemic treatment-emergent adverse events
Time frame: 34 days
# of TEAEs
3 secondary outcomes
Change from baseline in lesional Total Sign Score at Days 8, 15, and 22.
Time frame: 22 Days
Change from baseline in lesional Treatment Areas Assessment at Days 8, 15, and 22
Time frame: 22 Days
Change from baseline in skin barrier and biomarker levels at Day 22
Time frame: Day 22
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 20 Mar 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 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 2 study testing ATx201 2% Cream in people with Atopic Dermatitis, run by UNION therapeutics at 1 site in Canada.
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 3 inclusion and 26 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 20 Mar 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of local and systemic treatment-emergent adverse events (time frame: 34 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 20 Mar 2018.