Moderate to Severe Atopic DermatitisPhase 2NCT02426359
Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients
A Phase 2 study testing Q301 Cream in people with Moderate to Severe Atopic Dermatitis, run by Qurient Co., Ltd. at 7 sites in United States.
Trial summary
This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Atopic Dermatitis
- What is being tested?
- Q301 Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2015to May 2016
- 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
- Male or female subjects aged 18 or older
- Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
- Subjects with IGA score 3 or 4 corresponding to moderate to severe AD at screening and baseline visits
Who cannot join
- Subjects who had topical treatment with corticosteroids within 1 week before randomization
- Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatment within 4 weeks before randomization
- Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks before screening
- Subjects who participated in another drug trial within 4 weeks before screening
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Austin, Texas, 78759
Study site
Berlin, New Jersey, 08009
Study site
Buffalo, New York, 14203
Study site
College Station, Texas, 77845
Study site
Denver, Colorado, 80220
Study site
East Windsor, New Jersey, 08520
Study site
Winston-Salem, North Carolina, 27157
About this study
This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.
- Conditions
- Moderate to Severe Atopic Dermatitis
- Being tested
- Q301 Cream, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q301 CreamDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Q301 Cream | Experimental | Q301 Cream Receives: Drug: Q301 Cream |
| Vehicle | Placebo comparator | Vehicle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who have the IGA score of 0 or 1
Measured: Week 8
Secondary outcomes (4)
Percent change from baseline on the VAS for pruritus
Measured: Week 8
Percent change from baseline on the EASI
Measured: Week 8
Percent change from baseline on the SCORAD
Measured: Week 8
Percent change from baseline on the DLQI
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qurient Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426359
- Sponsor's protocol ID
- Q301-ADP2-US-01
- Status last verified
- May 2016
- First submitted
- 21 Apr 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT02426359
- Acronym / sponsor ID
- Q301-ADP2-US-01
- Conditions
- Moderate to Severe Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Qurient Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Apr 2015 (estimated)
- 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 randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Q301 Cream | Experimental | Drug: Q301 CreamQ301 Cream |
| Vehicle | Placebo comparator | Drug: PlaceboVehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects aged 18 or older
- Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
- Subjects with IGA score 3 or 4 corresponding to moderate to severe AD at screening and baseline visits
Key exclusion criteria (4 listed)
- Subjects who had topical treatment with corticosteroids within 1 week before randomization
- Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatment within 4 weeks before randomization
- Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks before screening
- Subjects who participated in another drug trial within 4 weeks before screening
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 |
|---|---|---|
| Q301 Cream | Drug | Q301 Cream |
| Placebo | Drug | Vehicle |
Primary outcome
Percentage of patients who have the IGA score of 0 or 1
Time frame: Week 8
4 secondary outcomes
Percent change from baseline on the VAS for pruritus
Time frame: Week 8
Percent change from baseline on the EASI
Time frame: Week 8
Percent change from baseline on the SCORAD
Time frame: Week 8
Percent change from baseline on the DLQI
Time frame: Week 8
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 6 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Q301 Cream in people with Moderate to Severe Atopic Dermatitis, run by Qurient Co., Ltd. at 7 sites 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 3 inclusion and 4 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 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Percentage of patients who have the IGA score of 0 or 1 (time frame: Week 8). 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 6 Dec 2016.