NCT03091426

Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

Completed Phase 2 Last updated 27 December 2017

What this trial tests

Phase 2 trial testing Omiganan in Atopic Dermatitis in 80 participants. Completed in 20 December 2017.

Timeline

8 March 2017

Primary endpoint
20 December 2017

20 December 2017

Quick facts

Lead sponsor	Maruho Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	8 March 2017
Primary completion	20 December 2017
Estimated completion	20 December 2017
Sites	1 location across Netherlands

Drugs / interventions tested

• Omiganan — full drug profile →
• Omiganan — full drug profile →
• Omiganan — full drug profile →
• Placebo

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Maruho Co., Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study has a randomized, double-blind, placebo-controlled design to assess the efficacy, pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic dermatitis when applied BID to all atopic dermatitis lesions.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. DRAMP 2.0, an updated data repository of antimicrobial peptides.
   Kang X, Dong F, Shi C, Liu S, et al · · 2019 · cited 230× · PMID 31409791 · DOI 10.1038/s41597-019-0154-y
2. The translational revolution in atopic dermatitis: the paradigm shift from pathogenesis to treatment.
   Facheris P, Jeffery J, Del Duca E, Guttman-Yassky E. · · 2023 · cited 150× · PMID 36928371 · DOI 10.1038/s41423-023-00992-4
3. Antimicrobial Peptides-Mechanisms of Action, Antimicrobial Effects and Clinical Applications.
   Talapko J, Meštrović T, Juzbašić M, Tomas M, et al · · 2022 · cited 140× · PMID 36290075 · DOI 10.3390/antibiotics11101417
4. Strategies in Translating the Therapeutic Potentials of Host Defense Peptides.
   Ting DSJ, Beuerman RW, Dua HS, Lakshminarayanan R, et al · · 2020 · cited 72× · PMID 32528474 · DOI 10.3389/fimmu.2020.00983
5. Human Defensins: A Novel Approach in the Fight against Skin Colonizing <i>Staphylococcus</i> a<i>ureus</i>.
   Scudiero O, Brancaccio M, Mennitti C, Laneri S, et al · · 2020 · cited 44× · PMID 32326312 · DOI 10.3390/antibiotics9040198
6. Antimicrobial Peptides and Cell-Penetrating Peptides: Non-Antibiotic Membrane-Targeting Strategies Against Bacterial Infections.
   Huang X, Li G. · · 2023 · cited 30× · PMID 36879855 · DOI 10.2147/idr.s396566
7. Mobile e-diary application facilitates the monitoring of patient-reported outcomes and a high treatment adherence for clinical trials in dermatology.
   Rijsbergen M, Niemeyer-van der Kolk T, Rijneveld R, Pinckaers JHFM, et al · · 2020 · cited 26× · PMID 31419338 · DOI 10.1111/jdv.15872
8. Novel Therapeutic Strategies in the Topical Treatment of Atopic Dermatitis.
   Pinto LM, Chiricozzi A, Calabrese L, Mannino M, et al · · 2022 · cited 17× · PMID 36559261 · DOI 10.3390/pharmaceutics14122767