A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults

Atopic Dermatitis Clinical Trial

— LF-AD-09  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124318
• Other study ID #: 04/09-AVVA RUS
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 28, 2010
• Last updated: September 13, 2010
• Start date: May 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Avva Rus, JSC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Federal Service on surveillance in Healthcare and Social development (Roszdravnadzor)
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Lactofiltrum
Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days
• Placebo
Placebo 2 tablets 3 times a day before meals during 21 days

Locations

Country	Name	City	State
Russian Federation	Moscow Dermatovenerologic Clinical Dispensary ? 1	Moscow
Russian Federation	Moscow State University of Medicine and Dentistry	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
Avva Rus, JSC	Moscow Dermatovenerologic Clinical Dispensary ? 1, Moscow State University of Medicine and Dentistry

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 21 after start of the intervention	No
Secondary	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.	Day 30 after end of the intervention	No
Secondary	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.	Day 10 after start of the intervention	No
Secondary	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).	Day 10 after start of the intervention	No
Secondary	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).	Day 21 after start of the intervention	No
Secondary	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).	Day 30 after end of the intervention	No
Secondary	BRS Index	Behavioral rating scores (BRS) measures severity of itching.	Day 10 after start of the intervention	No
Secondary	BRS Index	Behavioral rating scores (BRS) measures severity of itching.	Day 21 after start of the intervention	No
Secondary	BRS Index	Behavioral rating scores (BRS) measures severity of itching.	Day 30 after end of the intervention	No
Secondary	Blood test	It includes routine blood cells' counting and measurement of erythrocyte sedimentation rate and serum concentration of hemoglobin.	Day 21 after start of the intervention	Yes
Secondary	Biochemical blood analysis	It includes routine measurements of serum concentrations of biochemical compounds including proteins, glucose, enzymes, creatinine, urea, potassium, sodium, bilirubin.	Day 21 after start of the intervention	Yes
Secondary	Urine analysis	It includes routine measurements of urine concentrations of biochemical compounds including proteins and glucose, counting of cells, detection of bacteria and urinometry.	Day 21 after start of the intervention	Yes