NCT01124318 (LF-AD-09) is a Phase 2/Phase 3 clinical trial of Lactofiltrum in Atopic Dermatitis, sponsored by Avva Rus, JSC.

Who is sponsoring NCT01124318?

NCT01124318 is sponsored by Avva Rus, JSC.

What drugs are being tested in NCT01124318?

Interventions in NCT01124318: Lactofiltrum, Placebo.

What condition does NCT01124318 study?

NCT01124318 studies Atopic Dermatitis.

Is NCT01124318 still recruiting?

NCT01124318 is currently completed. Last updated 13 September 2010.

Last reviewed 2010-09-13 · How we verify

NCT01124318: LF-AD-09

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2/Phase 3 Last updated 13 September 2010

What this trial tests

Phase 2/Phase 3 trial testing Lactofiltrum in Atopic Dermatitis in 90 participants. Completed in 1 September 2010.

Timeline

1 May 2010

Primary endpoint
1 September 2010

1 September 2010

Quick facts

Lead sponsor	Avva Rus, JSC
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	90
Start date	1 May 2010
Primary completion	1 September 2010
Estimated completion	1 September 2010
Sites	2 locations across Russia

Drugs / interventions tested

Lactofiltrum — full drug profile →
Placebo

Conditions studied

Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Avva Rus, JSC — full company profile →

Who can join

Adults 18 to 60, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi · Phase 1 · recruiting
NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis · Phase 2 · recruiting
NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting

Other Avva Rus, JSC trials

Trials by the same sponsor.

NCT06411314 — Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01124318 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Avva Rus, JSC
Last refreshed: 13 September 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01124318.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing