Atopic DermatitisPhase 2NCT00927212
Topical Application of AS101 for the Treatment of Atopic Dermatitis
A Phase 2 study testing AS101 ointment in people with Atopic Dermatitis, run by BioMAS Ltd at 1 site in Israel.
Trial summary
Atopic Dermatitis is a chronic non contagious disease that causes itchy, inflamed skin. The purpose of this study is to evaluate the safety and efficacy of topical AS101 ointment for the treatment of Atopic dermatitis. 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?
- AS101 ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Sep 2010
- 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
- Diagnosed Atopic Dermatitis for at least 6 months prior to enrollment.
- Diseased Body surface area (BSA) ≤ 20%.
- Male and Female ≥ 18.
- Adequate general health.
- Signed Informed consent form by the patient or his/her legal guardian.
- Patient must be able and willing to comply with all protocol requirements.
Who cannot join
- Patient who is unable to provide fully informed consent.
- Pregnant of breast-feeding females.
- Concomitant dermatologic or medical condition(s) which may interfere with the patient's response evaluation.
- Evidence of an infection in the targeted zones.
- Known sensitivity to any of the drug component.
- Immunocompromised patients.
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- Concomitant medications such as:
- Topical corticosteroid within 2 weeks prior to Day 1 visit;
- Systemic steroids and immunosuppressants within 1 month prior to Day 1 visit; *Systemic anti-histamines and antibiotics within 2 weeks prior to Day 1 visit; *Phototherapy within 4 weeks prior to Day 1 visit;
- Anticipated exaggerated exposure to sunlight during the whole treatment period and 4 weeks prior to Day 1 visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Uncontrolled Pilot Study to Compare 2% and 4% AS101 Ointment for the Treatment of Atopic Dermatitis
Atopic Dermatitis is a chronic non contagious disease that causes itchy, inflamed skin. The purpose of this study is to evaluate the safety and efficacy of topical AS101 ointment for the treatment of Atopic dermatitis.
Read the detailed description
Atopic dermatitis (AD) is the most common chronic inflammatory skin disease, affecting 10-20% of children and 2% of adults worldwide. The mechanism of AD is still not completely understood, but the disorder appears to result from the complex interaction between immunological responses, various susceptability genes, defects in skin barrier function, host and environmental factors and infectious agents. AS101 is a non toxic potent immunomodulator that has been shown to have beneficial effects in diverse pre clinical and clinical studies. Recently, AS101 has shown efficacy and safety in the treatment of mild to moderate Psoriasis which shares with AD a related immunological mechanism along with the AS101 ability to decrease the level of interleukins known to be involved ith the pathogenesis of AD.
- Conditions
- Atopic Dermatitis
- Being tested
- AS101 ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS101 ointmentDrug
Twice daily topical application
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 2% AS101 ointment Receives: Drug: AS101 ointment |
| Group 2 | Experimental | 4% AS101 ointment Receives: Drug: AS101 ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified SCORAD index
Measured: within 6 weeks treatment and 4 weeks follow up
Secondary outcomes (1)
Remission period
Measured: within 4 weeks post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: The trial started and halted due sponsor's considerations.
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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMAS Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix Pavlotsky, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927212
- Sponsor's protocol ID
- #76 REV 00
- Status last verified
- Jun 2011
- First submitted
- 23 Jun 2009
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Uncontrolled Pilot Study to Compare 2% and 4% AS101 Ointment for the Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00927212
- Acronym / sponsor ID
- #76 REV 00
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial started and halted due sponsor's considerations.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- BioMAS LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Jun 2009 (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.
Atopic Dermatitis is a chronic non contagious disease that causes itchy, inflamed skin. The purpose of this study is to evaluate the safety and efficacy of topical AS101 ointment for the treatment of Atopic dermatitis.
Detailed description
Atopic dermatitis (AD) is the most common chronic inflammatory skin disease, affecting 10-20% of children and 2% of adults worldwide. The mechanism of AD is still not completely understood, but the disorder appears to result from the complex interaction between immunological responses, various susceptability genes, defects in skin barrier function, host and environmental factors and infectious agents. AS101 is a non toxic potent immunomodulator that has been shown to have beneficial effects in diverse pre clinical and clinical studies. Recently, AS101 has shown efficacy and safety in the treatment of mild to moderate Psoriasis which shares with AD a related immunological mechanism along with the AS101 ability to decrease the level of interleukins known to be involved ith the pathogenesis of AD.
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 |
|---|---|---|
| Group 1 | Experimental | Drug: AS101 ointment2% AS101 ointment |
| Group 2 | Experimental | Drug: AS101 ointment4% AS101 ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed Atopic Dermatitis for at least 6 months prior to enrollment.
- Diseased Body surface area (BSA) ≤ 20%.
- Male and Female ≥ 18.
- Adequate general health.
- Signed Informed consent form by the patient or his/her legal guardian.
Key exclusion criteria (10 listed)
- Patient who is unable to provide fully informed consent.
- Pregnant of breast-feeding females.
- Concomitant dermatologic or medical condition(s) which may interfere with the patient's response evaluation.
- Evidence of an infection in the targeted zones.
- Known sensitivity to any of the drug component.
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 |
|---|---|---|
| AS101 ointmentTwice daily topical application | Drug | Group 1, Group 2 |
Primary outcome
Modified SCORAD index
Time frame: within 6 weeks treatment and 4 weeks follow up
1 secondary outcome
Remission period
Time frame: within 4 weeks post treatment completion
Results and safety
The study was stopped early (reason given: The trial started and halted due sponsor's considerations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
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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.
Felix Pavlotsky, MD principal investigator
Sheba Medical Center
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 AS101 ointment in people with Atopic Dermatitis, run by BioMAS Ltd at 1 site 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 17 Jul 2014. 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 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. 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 was stopped early (reason given: The trial started and halted due sponsor's considerations.). Results are not available in the source record.
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?
Modified SCORAD index (time frame: within 6 weeks treatment and 4 weeks follow up). 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 17 Jul 2014.