Atopic DermatitisPhase 2NCT04307862
Safety, Tolerability and Efficacy of ZEP-3Na (0.1% or 1%) Compared to Placebo in Subjects With Mild to Moderate Atopic Dermatitis
A Phase 2 study testing ZEP-3Na 0.1% and ZEP-3Na 1% in people with Atopic Dermatitis, run by Shulov Innovate for Science Ltd. 2012 at 10 sites in Israel.
Trial summary
This is a phase II, double blind study with ZEP-3NA 0.1% or 1% vs. vehicle-control in subjects with mild to moderate Atopic Dermatitis. The IP (Investigational Product) will be administered topically twice daily for 4 weeks in the double blind phase. Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ZEP-3Na 0.1% and ZEP-3Na 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 10 sitesIsrael
- Study dates
- 29 Dec 2019to Feb 2025
- 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 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female 5 to 75 years old, inclusive.
- Clinical diagnosis of Atopic Dermatitis (as defined by Hanifin and Rajka criteria).
- Atopic Dermatitis should be present for at least three months with stable disease for ≥ 1 month prior to screening.
- IGA score of 2 or 3 (mild or moderate) during screening and baseline.
- Women of child bearing potential must have a negative urine pregnancy test at screening and use an adequate contraceptive method throughout the study. Women of child bearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (such as: hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 24 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. Adequate method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom), abstinence or vasectomy. Males with partners of childbearing potential should inform them of their participation in this clinical study and use an adequate contraceptive method throughout the study.
- Willing and able to comply with study instructions and commit to attending all visits.
- The patient/parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form prior to performing any study-related procedure. Adolescents age >16 to 18 years old should be willing and able to sign Assent Form.
Who cannot join
- Unstable or actively infected atopic dermatitis.
- Concomitant dermatologic (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to study drug.
- Patients with Atopic Dermatitis affecting only the scalp will be excluded from the study. In addition, patients with the scalp representing ≥ 25% of the affected area will be excluded as well.
- Has received treatment two weeks prior to visit 2 (Day 1 of IP) with topical corticosteroids and/or topical immunosuppressive drugs or four weeks prior to visit 2 (Day 1 of IP) with systemic immunosuppressive drugs and/or corticosteroids or plans to receive treatment during the study timeframe with immunosuppressive drugs and/or corticosteroids (topical or systemic).
- Use of Crisaborole two weeks prior to visit 2 (Day 1 of IP).
- Prior use of Dupilumab.
Show all 21Show fewer
- Subjects who are using any concomitant medications that, in the investigator's opinion, could affect the subject's atopic dermatitis (e.g Antihistamines). Subjects using such medications and have been stable on treatment for at least one month prior to visit 2 (Day 1 of IP) and no changes to these medications are planned during study, may be included in the study, at the investigator's discretion.
- Subject had UVA or UVB therapy two weeks prior to visit 2 (Day 1 of IP) or is due to have it during the study period.
- Any vaccination in the last 30 days prior to the screening visit. However, due to COVID-19 pandemic, only 1st vaccination for COVID is not allowed during only 21 days prior to visit 2 (Day 1 of IP) and during the study. The 2nd vaccination onwards is allowed at all times.
- Abnormal renal function (defined as serum creatinine >1.5xULN).
- Abnormal liver function (defined as any transaminases >2xULN).
- Clinically significant abnormalities as determined by the Investigator on the 12-lead ECG conducted at the screening visit (for adults only).
- Subject has active or history of malignancy, except non melanomatous skin cancer cured by excision. Subjects with past malignancy who had completed therapy and are free of the disease for at least 5 years may be included in the study, at the investigator's discretion.
- History of immunodeficiency syndrome (e.g. atypical rash morphology, severe bacterial, fungal or viral skin infections, etc).
- Subjects who are receiving any investigational drug or who participated in a clinical trial with an investigational product within the last 30 days or 5-half-lives of the investigational product, whichever is longer.
- History of any anaphylactic reaction or history or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis and atopic dermatitis).
- Known hypersensitivity to any of the components of the study drug.
- Known or suspected history of alcohol or drug abuse.
- Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history.
- Pregnant or lactating women.
- Any history which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Israel10 sites, 6 recruiting
- Terminated
Ha'Emek MC
Afula
- Terminated
Barzilai MC
Ashkelon
- Recruiting
Rambam MC
Haifa
Michal Ramon, MD, 0502063228, m_ramon@rambam.health.gov.il
Maoraj Abu Raya, 0524121005, mao_aburaya@rambam.health.gov.il
- Recruiting
Shaare Zedek MC
Jerusalem
Tali Czarnowicki, Prof., +972 2 5645676, talicz@szmc.org.il
- Recruiting
Clalit Health Services
Kfar Saba
Shmuel Gur, MD, 0505550741, gursh@clalit.org.il
Or ly Gelman, 0544533545, Orlyge@clalit.org.il
- Recruiting
Prof. Shemer Clinic affiliated to Laniado MC
Netanya
Avner Shemer, Prof., +972 77 5610063, havti333@gmail.com
- Withdrawn
Clalit Health Services
Petah Tikva
- Withdrawn
Clalit Health Services
Ramla
- Recruiting
Kaplan MC
Rehovot
Daniel Elbirt, Dr., +972 8 9441909, yafitra1@clalit.org.il
- Recruiting
Tel-Aviv Sourasky MC
Tel Aviv
Liat Samuelov, Dr., +972 3 6973585, gayach@tlvmc.gov.il
About this study
Official title: A Phase II Multicenter, Randomized, Double Blind Study to Assess the Safety, Tolerability and Efficacy of Two Concentrations of ZEP-3Na Topical Cream (0.1% and 1%) Compared to Vehicle-control in Subjects With Mild to Moderate Atopic Dermatitis With an Open Label Extension of up to 2 Weeks Treatment With ZEP-3Na Topical Cream 1%
This is a phase II, double blind study with ZEP-3NA 0.1% or 1% vs. vehicle-control in subjects with mild to moderate Atopic Dermatitis. The IP (Investigational Product) will be administered topically twice daily for 4 weeks in the double blind phase. patients that will reach the primary endpoint will have the opportunity for additional to two weeks of open label treatment with ZEP-3Na 1%.
The purpose of this study is to assess the safety, tolerability and efficacy of two concentrations of ZEP-3NA compared to vehicle-control.
Read the detailed description
165 subjects, 5-75 years old with mild to moderate Atopic Dermatitis will be enrolled to the study.
The investigational product which is the synthetic analogue of the natural compound found in the rattle snake venom will be administered topically twice daily.
The duration of the study will be up to 11 weeks consisting of up to 3 weeks of screening, 4 weeks of double blind treatment, optional 2 weeks of open label treatment, followed by 2 weeks of follow-up.
Efficacy will be measured by IGA (Investigator Global Assessment, EASI (Eczema Area and Severity Index) and SCORAD (SCORing Atopic Dermatitis).
Lesions will be photographed throughout the study. Physical examination and vital signs will be measured during every visit. Patients will complete quality of life questionnaires, itching scale and diaries.
- Conditions
- Atopic Dermatitis
- Being tested
- ZEP-3Na 0.1%, ZEP-3Na 1%, Placebo Vehicle only
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEP-3Na 0.1%Drug
The Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase
ZEP-3Na 1%Drug
The Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase, with optional 2 weeks of open label with ZEP-3Na 1%.
Placebo Vehicle onlyDrug
he Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase
| Study group | Role | What they receive |
|---|---|---|
| ZEP-3Na 0.1% | Experimental | The ZEP-3Na 0.1% cream will be applied topically twice daily Receives: Drug: ZEP-3Na 0.1% |
| ZEP-3Na 1% | Experimental | The ZEP-3Na 1% cream will be applied topically twice daily Receives: Drug: ZEP-3Na 1% |
| Vehicle Control | Placebo comparator | The Vehicle Control cream will be applied topically twice daily Receives: Drug: Placebo Vehicle only |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Proportion of subjects with IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ≥2 points during up to 4 weeks of double blind treatment
Lower score of IGA mean better outcome, higher score mean worse outcome
Measured: Up to 4 weeks
Secondary outcomes (16)
• Proportion of subjects with IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ≥2 points during up to 4 weeks of double blind treatment and following additional up to 2 weeks of an open label extension with ZEP 3Na 1%, if applicable
Lower score of IGA mean better outcome, higher score mean worse outcome
Measured: Up to 6 weeks
• Proportion of subjects with EASI-50 (≥50% improvement from baseline) at end of treatment visit (EoT of the double blind part and EoT of the open label part, if applicable).
Higher score mean better outcome, lower score mean worse outcome
Measured: Up to 6 weeks
• Percent change in EASI-50 score from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Higher score mean better outcome, lower score mean worse outcome
Measured: Up to 6 weeks
• Percent change from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable) in pruritus NRS.
Lower score of NRS mean better outcome, higher score mean worse outcome
Measured: Up to 6 weeks
• Proportion of subjects with improvement (reduction) of pruritus NRS ≥3 points from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Lower score of NRS mean better outcome, higher score mean worse outcome
Measured: Up to 6 weeks
• Change from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable) in SCORAD.
Lower score of SCORAD mean better outcome, higher score mean worse outcome
Measured: Up to 6 weeks
• Distribution of disease severity scores (eg, IGA, EASI, SCORAD) and their change from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Measured: Up to 6 weeks
• Proportion of subjects who achieve reduction of IGA score by ≥1 from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Measured: Up to 6 weeks
• Proportion of subjects who achieve reduction of IGA score by ≥2 from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Measured: Up to 6 weeks
Time to ≥1 point improvement in IGA.
Lower score mean better outcome, higher score mean worse outcome
Measured: Up to 6 weeks
• Time to > 2 points improvement in IGA.
Lower score mean better outcome, higher score mean worse outcome
Measured: Up to 6 weeks
• Change from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable) in DLQI.
Measured: Up to 6 weeks
• Incidence of skin infection treatment-emergent adverse events (TEAE) requiring systemic treatment from baseline through EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Measured: Up to 6 weeks
• Incidence of treatment-emergent serious adverse events (TESAEs) from baseline through EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Measured: Up to 6 weeks
• Incidence of TEAEs leading to treatment discontinuation from baseline through EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Measured: Up to 6 weeks
• Overall incidence of TEAEs through EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start29 Dec 2019
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shulov Innovate for Science Ltd. 2012
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307862
- Sponsor's protocol ID
- ZEP-003-IL
- Status last verified
- Sep 2023
- First submitted
- 24 Nov 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter, Randomized, Double Blind Study to Assess the Safety, Tolerability and Efficacy of Two Concentrations of ZEP-3Na Topical Cream (0.1% and 1%) Compared to Vehicle-control in Subjects With Mild to Moderate Atopic Dermatitis With an Open Label Extension of up to 2 Weeks Treatment With ZEP-3Na Topical Cream 1%
- ClinicalTrials.gov ID
- NCT04307862
- Acronym / sponsor ID
- ZEP-003-IL
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Shulov Innovate for Science Ltd. 2012Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 13 Mar 2020 (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 II, double blind study with ZEP-3NA 0.1% or 1% vs. vehicle-control in subjects with mild to moderate Atopic Dermatitis. The IP (Investigational Product) will be administered topically twice daily for 4 weeks in the double blind phase. patients that will reach the primary endpoint will have the opportunity for additional to two weeks of open label treatment with ZEP-3Na 1%.
The purpose of this study is to assess the safety, tolerability and efficacy of two concentrations of ZEP-3NA compared to vehicle-control.
Detailed description
165 subjects, 5-75 years old with mild to moderate Atopic Dermatitis will be enrolled to the study.
The investigational product which is the synthetic analogue of the natural compound found in the rattle snake venom will be administered topically twice daily.
The duration of the study will be up to 11 weeks consisting of up to 3 weeks of screening, 4 weeks of double blind treatment, optional 2 weeks of open label treatment, followed by 2 weeks of follow-up.
Efficacy will be measured by IGA (Investigator Global Assessment, EASI (Eczema Area and Severity Index) and SCORAD (SCORing Atopic Dermatitis).
Lesions will be photographed throughout the study. Physical examination and vital signs will be measured during every visit. Patients will complete quality of life questionnaires, itching scale and diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZEP-3Na 0.1% | Experimental | Drug: ZEP-3Na 0.1%The ZEP-3Na 0.1% cream will be applied topically twice daily |
| ZEP-3Na 1% | Experimental | Drug: ZEP-3Na 1%The ZEP-3Na 1% cream will be applied topically twice daily |
| Vehicle Control | Placebo comparator | Drug: Placebo Vehicle onlyThe Vehicle Control cream will be applied topically twice daily |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female 5 to 75 years old, inclusive.
- Clinical diagnosis of Atopic Dermatitis (as defined by Hanifin and Rajka criteria).
- Atopic Dermatitis should be present for at least three months with stable disease for ≥ 1 month prior to screening.
- IGA score of 2 or 3 (mild or moderate) during screening and baseline.
- Women of child bearing potential must have a negative urine pregnancy test at screening and use an adequate contraceptive method throughout the study. Women of child bearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (such as: hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 24 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. Adequate method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom), abstinence or vasectomy. Males with partners of childbearing potential should inform them of their participation in this clinical study and use an adequate contraceptive method throughout the study.
Key exclusion criteria (21 listed)
- Unstable or actively infected atopic dermatitis.
- Concomitant dermatologic (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to study drug.
- Patients with Atopic Dermatitis affecting only the scalp will be excluded from the study. In addition, patients with the scalp representing ≥ 25% of the affected area will be excluded as well.
- Has received treatment two weeks prior to visit 2 (Day 1 of IP) with topical corticosteroids and/or topical immunosuppressive drugs or four weeks prior to visit 2 (Day 1 of IP) with systemic immunosuppressive drugs and/or corticosteroids or plans to receive treatment during the study timeframe with immunosuppressive drugs and/or corticosteroids (topical or systemic).
- Use of Crisaborole two weeks prior to visit 2 (Day 1 of IP).
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 |
|---|---|---|
| ZEP-3Na 0.1%The Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase | Drug | ZEP-3Na 0.1% |
| ZEP-3Na 1%The Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase, with optional 2 weeks of open label with ZEP-3Na 1%. | Drug | ZEP-3Na 1% |
| Placebo Vehicle onlyhe Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase | Drug | Vehicle Control |
Primary outcome
• Proportion of subjects with IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ≥2 points during up to 4 weeks of double blind treatment
Time frame: Up to 4 weeks
Lower score of IGA mean better outcome, higher score mean worse outcome
16 secondary outcomes
• Proportion of subjects with IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ≥2 points during up to 4 weeks of double blind treatment and following additional up to 2 weeks of an open label extension with ZEP 3Na 1%, if applicable
Time frame: Up to 6 weeks
• Proportion of subjects with EASI-50 (≥50% improvement from baseline) at end of treatment visit (EoT of the double blind part and EoT of the open label part, if applicable).
Time frame: Up to 6 weeks
• Percent change in EASI-50 score from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Time frame: Up to 6 weeks
• Percent change from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable) in pruritus NRS.
Time frame: Up to 6 weeks
• Proportion of subjects with improvement (reduction) of pruritus NRS ≥3 points from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Time frame: Up to 6 weeks
• Change from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable) in SCORAD.
Time frame: Up to 6 weeks
• Distribution of disease severity scores (eg, IGA, EASI, SCORAD) and their change from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Time frame: Up to 6 weeks
• Proportion of subjects who achieve reduction of IGA score by ≥1 from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Time frame: Up to 6 weeks
• Proportion of subjects who achieve reduction of IGA score by ≥2 from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Time frame: Up to 6 weeks
Time to ≥1 point improvement in IGA.
Time frame: Up to 6 weeks
• Time to > 2 points improvement in IGA.
Time frame: Up to 6 weeks
• Change from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable) in DLQI.
Time frame: Up to 6 weeks
• Incidence of skin infection treatment-emergent adverse events (TEAE) requiring systemic treatment from baseline through EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Time frame: Up to 6 weeks
• Incidence of treatment-emergent serious adverse events (TESAEs) from baseline through EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Time frame: Up to 6 weeks
• Incidence of TEAEs leading to treatment discontinuation from baseline through EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Time frame: Up to 6 weeks
• Overall incidence of TEAEs through EoT (EoT of the double blind part and EoT of the open label part, if applicable).
Time frame: Up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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.
10 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 ZEP-3Na 0.1% and ZEP-3Na 1% in people with Atopic Dermatitis, run by Shulov Innovate for Science Ltd. 2012 at 10 sites in Israel.
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 21 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Proportion of subjects with IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ≥2 points during up to 4 weeks of double blind treatment (time frame: Up to 4 weeks). 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 13 Sep 2023.