Clinical trial NCT01124318: A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Atopic Dermatitis
Keywords: Lactofiltrum
atopic dermatitis
itching
Dermatological Index of Life Quality
SCORAD
Behavioral Rating Scores
Lead sponsor: Avva Rus, JSC
Sponsor class: INDUSTRY
Collaborators: name: Moscow State University of Medicine and Dentistry
name: Moscow Dermatovenerologic Clinical Dispensary № 1
First posted: 2010-05-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. Additionally, lactulose stimulates Bifidobacterium flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: SCORAD Index
timeFrame: Day 21 after start of the intervention
Secondary outcomes:
measure: SCORAD Index
timeFrame: Day 30 after end of the intervention
measure: SCORAD Index
timeFrame: Day 10 after start of the intervention
measure: Dermatological Index of Life Quality
timeFrame: Day 10 after start of the intervention
measure: Dermatological Index of Life Quality
timeFrame: Day 21 after start of the intervention
measure: Dermatological Index of Life Quality
timeFrame: Day 30 after end of the intervention
measure: BRS Index
timeFrame: Day 10 after start of the intervention
measure: BRS Index
timeFrame: Day 21 after start of the intervention
measure: BRS Index
timeFrame: Day 30 after end of the intervention
measure: Blood test
timeFrame: Day 21 after start of the intervention
measure: Biochemical blood analysis
timeFrame: Day 21 after start of the intervention
measure: Urine analysis
timeFrame: Day 21 after start of the intervention
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Dermatovenerologic Clinical Dispensary № 1
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry
Study officials:
affiliation: Moscow State University of Medicine and Dentistry
name: Yuriy Perlamutrov, MD, DrSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Avva Rus, JSC
name: Nickolay A. Kryuchkov, MD, PhD, MPH
role: STUDY_DIRECTOR
affiliation: Avva Rus, JSC
name: Lyudmila Kobeleva, MD, PhD
role: STUDY_DIRECTOR
References: