Atopic DermatitisPhase 2/3LF-AD-09NCT01124318
A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults
A Phase 2/3 study testing Lactofiltrum in people with Atopic Dermatitis, run by Avva Rus, JSC at 2 sites in Russia.
Trial summary
The purpose is to study efficacy of Lactofiltrum in adult patients with atopic dermatitis. Lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to normalize metabolic and immune processes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lactofiltrum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesRussia
- Study dates
- May 2010to Sep 2010
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients aged 18-60 y.o. diagnosed with atopic dermatitis according to the UK refinement of the Hanifin-Rajka diagnostic criteria;
- SCORAD Index more than 25.
Who cannot join
- pregnancy and breast-feeding;
- severe diseases;
- concomitant infection diseases (including parasitic ones);
- diffusive connective-tissue (autoimmune) diseases;
- renal and hepatic failure;
- systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolite agents by the time of inclusion into the study;
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- concomitant skin diseases: skin lymphoma, scab, lichen ruber planus, psoriasis;
- professional activity involving skin injury, exposure to cold, insolation, ultraviolet radiation;
- psychoses;
- application of pre-, probiotics, antibiotics, neuroleptics or tranquilizers 2 weeks before inclusion or during participation in the study;
- participation in other clinical study 1 month before inclusion or during participation in the proposed study.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Moscow Dermatovenerologic Clinical Dispensary № 1
Moscow, Moscow, 119071
Moscow State University of Medicine and Dentistry
Moscow, Moscow, 127473
About this study
Official title: Phase II Double Blind Placebo-controled Randomized Comparative Multicentered Study of Efficacy and Safety of Lactofiltrum, Orally Administered Tablets (Produced by AVVA RUS, JSC) to Treat Atopic Dermatitis in Adults
The purpose is to study efficacy of Lactofiltrum in adult patients with atopic dermatitis. Lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to normalize metabolic and immune processes. Additionally, lactulose stimulates Bifidobacterium flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Lactofiltrum, Placebo
- Keywords
- Lactofiltrum, atopic dermatitis, itching, Dermatological Index of Life Quality, SCORAD, Behavioral Rating Scores
- Medical subject headings
- Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactofiltrumDrug
Also called Lactulose, Lignin
Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days
PlaceboDrug
Placebo 2 tablets 3 times a day before meals during 21 days
| Study group | Role | What they receive |
|---|---|---|
| Lactofiltrum | Active comparator | Not described Receives: Drug: Lactofiltrum |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD Index
The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms.
Measured: Day 21 after start of the intervention
Secondary outcomes (11)
SCORAD Index
The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms.
Measured: Day 30 after end of the intervention
SCORAD Index
The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms.
Measured: Day 10 after start of the intervention
Dermatological Index of Life Quality
The Dermatological Index of Life Quality is a index (0-30 scores) representing patient's life quality deteriorations related to a skin disease (self-reported questionnaire).
Measured: Day 10 after start of the intervention
Dermatological Index of Life Quality
The Dermatological Index of Life Quality is a index (0-30 scores) representing patient's life quality deteriorations related to a skin disease (self-reported questionnaire).
Measured: Day 21 after start of the intervention
Dermatological Index of Life Quality
The Dermatological Index of Life Quality is a index (0-30 scores) representing patient's life quality deteriorations related to a skin disease (self-reported questionnaire).
Measured: Day 30 after end of the intervention
BRS Index
Behavioral rating scores (BRS) measures severity of itching.
Measured: Day 10 after start of the intervention
BRS Index
Behavioral rating scores (BRS) measures severity of itching.
Measured: Day 21 after start of the intervention
BRS Index
Behavioral rating scores (BRS) measures severity of itching.
Measured: Day 30 after end of the intervention
Blood test
It includes routine blood cells' counting and measurement of erythrocyte sedimentation rate and serum concentration of hemoglobin.
Measured: Day 21 after start of the intervention
Biochemical blood analysis
It includes routine measurements of serum concentrations of biochemical compounds including proteins, glucose, enzymes, creatinine, urea, potassium, sodium, bilirubin.
Measured: Day 21 after start of the intervention
Urine analysis
It includes routine measurements of urine concentrations of biochemical compounds including proteins and glucose, counting of cells, detection of bacteria and urinometry.
Measured: Day 21 after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionSep 2010
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avva Rus, JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Moscow State University of Medicine and Dentistry, Moscow Dermatovenerologic Clinical Dispensary № 1
- Investigators
- Yuriy Perlamutrov, MD, DrSc, Principal investigator, Moscow State University of Medicine and DentistryNickolay A. Kryuchkov, MD, PhD, MPH, Study director, Avva Rus, JSCLyudmila Kobeleva, MD, PhD, Study director, Avva Rus, JSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124318
- Sponsor's protocol ID
- 04/09-AVVA RUS
- Acronym
- LF-AD-09
- Status last verified
- Sep 2010
- First submitted
- 28 Apr 2010
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Double Blind Placebo-controled Randomized Comparative Multicentered Study of Efficacy and Safety of Lactofiltrum, Orally Administered Tablets (Produced by AVVA RUS, JSC) to Treat Atopic Dermatitis in Adults
- ClinicalTrials.gov ID
- NCT01124318
- Acronym / sponsor ID
- LF-AD-09 / 04/09-AVVA RUS
- Conditions
- Atopic Dermatitis
- Keywords
- Lactofiltrum, atopic dermatitis, itching, Dermatological Index of Life Quality, SCORAD, Behavioral Rating Scores
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Avva Rus, JSCIndustry (pharma, biotech, devices)
- Collaborators
- Moscow State University of Medicine and Dentistry, Moscow Dermatovenerologic Clinical Dispensary № 1
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 May 2010 (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.
The purpose is to study efficacy of Lactofiltrum in adult patients with atopic dermatitis. Lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to normalize metabolic and immune processes. Additionally, lactulose stimulates Bifidobacterium flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.
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 |
|---|---|---|
| Lactofiltrum | Active comparator | Drug: Lactofiltrum |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients aged 18-60 y.o. diagnosed with atopic dermatitis according to the UK refinement of the Hanifin-Rajka diagnostic criteria;
- SCORAD Index more than 25.
Key exclusion criteria (11 listed)
- pregnancy and breast-feeding;
- severe diseases;
- concomitant infection diseases (including parasitic ones);
- diffusive connective-tissue (autoimmune) diseases;
- renal and hepatic failure;
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 |
|---|---|---|
| LactofiltrumAlso: Lactulose, LigninLactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days | Drug | Lactofiltrum |
| PlaceboPlacebo 2 tablets 3 times a day before meals during 21 days | Drug | Placebo |
Primary outcome
SCORAD Index
Time frame: Day 21 after start of the intervention
The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms.
11 secondary outcomes
SCORAD Index
Time frame: Day 30 after end of the intervention
SCORAD Index
Time frame: Day 10 after start of the intervention
Dermatological Index of Life Quality
Time frame: Day 10 after start of the intervention
Dermatological Index of Life Quality
Time frame: Day 21 after start of the intervention
Dermatological Index of Life Quality
Time frame: Day 30 after end of the intervention
BRS Index
Time frame: Day 10 after start of the intervention
BRS Index
Time frame: Day 21 after start of the intervention
BRS Index
Time frame: Day 30 after end of the intervention
Blood test
Time frame: Day 21 after start of the intervention
Biochemical blood analysis
Time frame: Day 21 after start of the intervention
Urine analysis
Time frame: Day 21 after start of the intervention
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 14 Sep 2010.
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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.
Yuriy Perlamutrov, MD, DrSc principal investigator
Moscow State University of Medicine and Dentistry
Nickolay A. Kryuchkov, MD, PhD, MPH study director
Avva Rus, JSC
Lyudmila Kobeleva, MD, PhD study director
Avva Rus, JSC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lactofiltrum in people with Atopic Dermatitis, run by Avva Rus, JSC at 2 sites in Russia.
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 2 inclusion and 11 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 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
SCORAD Index (time frame: Day 21 after start of the intervention). 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 14 Sep 2010.