NCT01429701

Brief Summary

Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The purpose of this trial is evaluate the effectiveness of two different topic associations of drugs.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 24, 2021

Status Verified

March 1, 2013

Enrollment Period

1 month

First QC Date

September 5, 2011

Last Update Submit

February 23, 2021

Conditions

Eczema

Keywords

DermatitisDermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

  • Reduction / improvement of signs and symptoms

    The reduction of signs and symptoms will be evaluated by OSAAD index.

    DAY 22

Secondary Outcomes (1)

  • Adverse Events Evaluation

    DAY 22

Study Arms (2)

Test association cream

EXPERIMENTAL

polymyxin B sulphate + prednisolone + benzocaine + clioquinol

Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol

Comparative association cream

ACTIVE COMPARATOR

betamethasone + gentamicin + tolnaftato + clioquinol

Drug: betamethasone + gentamicin + tolnaftato + cleoquinol

Interventions

polymyxin B sulphate + prednisolone + benzocaine + clioquinolDRUG

applied 3 times / day at lesion

Test association cream
betamethasone + gentamicin + tolnaftato + cleoquinolDRUG

applied 3 times / day at lesion

Comparative association cream

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must be able to understand the study procedures agree to participate and give written consent.
  • Patients with acute or subacute dermatitis with a minimum of 3 symptoms.

You may not qualify if:

  • Pregnancy or risk of pregnancy.
  • Lactation
  • Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).
  • Sunlight over exposure in the last 15 days.
  • Any pathology or past medical condition that can interfere with this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EczemaDermatitisDermatitis, Atopic

Interventions

Polymyxin BPrednisoloneBenzocaineClioquinolBetamethasoneGentamicinsTolnaftate

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteinsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring Compoundspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOxyquinolineHydroxyquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSteroids, FluorinatedAminoglycosidesGlycosidesCarbohydratesThiocarbamatesCarbamatesAcids, AcyclicNaphthalenesPolycyclic Aromatic HydrocarbonsSulfur Compounds

Study Officials

  • Flávia Addór, MD.

    Medicin Instituto da Pele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2011

First Posted

September 7, 2011

Study Start

May 1, 2012

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

February 24, 2021

Record last verified: 2013-03