Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous

Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + Clioquinol in Acute and Sub-acute Dermatitis Eczematous

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01429701

Enrollment

Registered

2011-09-07

Start date

2012-05-31

Completion date

2012-08-31

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eczema

Keywords

Dermatitis, Dermatitis, Atopic

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.

Detailed description

Study design: * Experiment duration: 22 days * 2 visits (days 0,7,15 and 22) * Reducing eczema area and severity index evaluation * Adverse events evaluation * Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.

Interventions

DRUGpolymyxin B sulphate + prednisolone + benzocaine + clioquinol

applied 3 times / day at lesion

DRUGbetamethasone + gentamicin + tolnaftato + cleoquinol

applied 3 times / day at lesion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

1. Patients must be able to understand the study procedures agree to participate and give written consent. 2. Patients with acute or subacute dermatitis with a minimum of 3 symptoms.

Exclusion criteria

1. Pregnancy or risk of pregnancy. 2. Lactation 3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study). 4. Sunlight over exposure in the last 15 days. 5. Any pathology or past medical condition that can interfere with this protocol.

Design outcomes

Primary

Measure	Time frame	Description
Reduction / improvement of signs and symptoms	DAY 22	The reduction of signs and symptoms will be evaluated by OSAAD index.

Secondary

Measure	Time frame	Description
Adverse Events Evaluation	DAY 22	Adverse events will be collected and followed in order to evaluate safety and tolerability.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026