Atopic DermatitisPhase 2NCT03351777
Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis
A Phase 2 study testing PR022 in people with Atopic Dermatitis, run by Realm Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- PR022
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 to 65 years of age
- EASI score ≤ 21 at baseline
- Diagnosis of mild-to-moderate (grade 2 or 3) AD according to the ISGA scale at Baseline
- BSA affected by AD: 5% to 20% at start of treatment
- Willing and able to apply study treatments as directed, comply with study instructions, and commit to attending all visits
- Willing and able to provide informed consent
- Use of adequate birth control, if of reproductive potential and sexually active
Who cannot join
- Widespread AD requiring systemic therapy
- Use of any of the following treatments within the specified time periods prior to Day 1
- Topical medications (topical antibiotics, topical corticosteroids, topical antifungals, topical antihistamines, topical retinoids, topical calcipotriene, tacrolimus, pimecrolimus, or other topical drug products for treatment of AD) or bleach bath within 2 weeks prior to Day 1
- Systemic agents (cyclosporine, systemic corticosteroids [oral and injectable; intranasal and inhaled corticosteroids are allowed if use is kept constant during the study], systemic antibiotics, immunomodulators or immunosuppressive therapies, interferon, cytotoxic drugs [e.g., methotrexate, cyclophosphamide, azathioprine], oral retinoids, systemic antifungals, tacrolimus) for the treatment of AD within 4 weeks prior to Day 1
- Ultraviolet (UV) therapy or use of a tanning booth/parlor within 6 weeks prior to Day 1
- Biologic therapies within 12 weeks (or 5 half-lives) prior to Day 1
Show all 14Show fewer
- Antihistamines within 5 days prior to Day 1 [stable regimens (consistent use ≥ 14 days before Day 1) of oral H1 antihistamines for non-AD lesion treatment will be allowed]
- Active or potentially recurrent dermatologic condition other than AD that may confound evaluation
- Congenital ichthyosis (note that subjects with ichthyosis vulgaris are permitted)
- Known allergy to any ingredients of the investigational product formulation
- Significant confounding conditions as assessed by Investigator
- Any condition that could interfere with any evaluation in the study
- Pregnancy or breast feeding
- Any reason which, in the opinion of the Investigator, interferes with the ability of the subject to participate in or complete the trial
Trial locations and contacts
1 site in 1 country.
Kathy Goin contact
United States1 site, 1 recruiting
- Recruiting
Principal Investigator
Philadelphia, Pennsylvania, 19148
Principal Investigator
About this study
The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
- Conditions
- Atopic Dermatitis
- Being tested
- PR022
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PR022Drug
Topical Gel
| Study group | Role | What they receive |
|---|---|---|
| PR022 topical gel, 0.05% | Experimental | Applied twice daily for 28 days Receives: Drug: PR022 |
| PR022 topical gel, 0.1% | Experimental | Applied twice daily for 28 days Receives: Drug: PR022 |
| PR022 topical gel vehicle | Placebo comparator | Applied twice daily for 28 days Receives: Drug: PR022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI)
Measured: 29 days
Secondary outcomes (10)
Percentage of subjects who achieved success in Investigator's Static Global Assessment (ISGA), defined as a score of "Clear" (0) or "Almost Clear" (1) with a minimum 2-grade improvement at Day 29
Measured: 29 Days
Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29
Measured: 29 Days
Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29
Measured: 29 Days
Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29
Measured: 29 Days
Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD
Measured: 29 Days
Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD)
Measured: 29 Days
Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS)
Measured: 29 Days
Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale
Measured: 29 days
Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI)
Measured: 29 days
Frequency counts and percentages of DLQI scores (scored 0 to 3) at Baseline and Day 29, as well as shift in DLQI scores from Baseline to Day 29
Measured: 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start4 Dec 2017
- Primary completionApr 2018 (estimated)
- Study completionJul 2018 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Realm Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Peters, MD, PhD, Study director, Realm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351777
- Sponsor's protocol ID
- REALM-1
- Status last verified
- Dec 2017
- First submitted
- 20 Nov 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03351777
- Acronym / sponsor ID
- REALM-1
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Realm Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 24 Nov 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.
The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PR022 topical gel, 0.05% | Experimental | Drug: PR022Applied twice daily for 28 days |
| PR022 topical gel, 0.1% | Experimental | Drug: PR022Applied twice daily for 28 days |
| PR022 topical gel vehicle | Placebo comparator | Drug: PR022Applied twice daily for 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects 18 to 65 years of age
- EASI score ≤ 21 at baseline
- Diagnosis of mild-to-moderate (grade 2 or 3) AD according to the ISGA scale at Baseline
- BSA affected by AD: 5% to 20% at start of treatment
- Willing and able to apply study treatments as directed, comply with study instructions, and commit to attending all visits
Key exclusion criteria (14 listed)
- Widespread AD requiring systemic therapy
- Use of any of the following treatments within the specified time periods prior to Day 1
- Topical medications (topical antibiotics, topical corticosteroids, topical antifungals, topical antihistamines, topical retinoids, topical calcipotriene, tacrolimus, pimecrolimus, or other topical drug products for treatment of AD) or bleach bath within 2 weeks prior to Day 1
- Systemic agents (cyclosporine, systemic corticosteroids [oral and injectable; intranasal and inhaled corticosteroids are allowed if use is kept constant during the study], systemic antibiotics, immunomodulators or immunosuppressive therapies, interferon, cytotoxic drugs [e.g., methotrexate, cyclophosphamide, azathioprine], oral retinoids, systemic antifungals, tacrolimus) for the treatment of AD within 4 weeks prior to Day 1
- Ultraviolet (UV) therapy or use of a tanning booth/parlor within 6 weeks prior to Day 1
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 |
|---|---|---|
| PR022Topical Gel | Drug | PR022 topical gel vehicle, PR022 topical gel, 0.05%, PR022 topical gel, 0.1% |
Primary outcome
Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI)
Time frame: 29 days
10 secondary outcomes
Percentage of subjects who achieved success in Investigator's Static Global Assessment (ISGA), defined as a score of "Clear" (0) or "Almost Clear" (1) with a minimum 2-grade improvement at Day 29
Time frame: 29 Days
Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29
Time frame: 29 Days
Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29
Time frame: 29 Days
Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29
Time frame: 29 Days
Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD
Time frame: 29 Days
Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD)
Time frame: 29 Days
Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS)
Time frame: 29 Days
Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale
Time frame: 29 days
Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI)
Time frame: 29 days
Frequency counts and percentages of DLQI scores (scored 0 to 3) at Baseline and Day 29, as well as shift in DLQI scores from Baseline to Day 29
Time frame: 29 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
Kathy Goin contact
Christian Peters, MD, PhD study director
Realm
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 PR022 in people with Atopic Dermatitis, run by Realm Therapeutics, Inc. 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 21 Dec 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie Crossley (4843212700, Valerie@realmtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI) (time frame: 29 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 21 Dec 2017.