Effectiveness of Clemastine Fumarate + Dexamethasone Comp... | NCT01257061

Studies
Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment

NCT01257061

Sponsor

EMS

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

310Actual

Phase

Phase 3

Conditions

Eczema

Interventions

Group 1
Group 2

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 6, 2012Actual

Primary Completion Date

Apr 30, 2013Actual

Completion Date

Aug 2, 2013Actual

First Submitted Date

Nov 29, 2010

First Submission Date that Met QC Criteria

Dec 8, 2010

First Posted Date

Dec 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2020

Last Update Posted Date

Jul 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Atopic dermatitis 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 propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.

Detailed Description

Study design:

• Double blinded, superiority, prospective parallel-group, intend to treat trial.

Study design:

Experiment duration: 22 days
2 visits (days 1,7,15 and 22)
Reducing Eczema Area and severity index evaluation
Adverse events evaluation

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

310Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g	Drug: Group 1
Group 2	Active Comparator	Dexchlorpheniramine maleate 10 mg/g	Drug: Group 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group 1	Drug	Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion	Group 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be able to understand the study procedures agree to participate and give written consent.
Patients with acute or sub-acute eczema.
Presence of symmetric lesions to compare on side to the other.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Flavia Addor, MD	Medcin Instituto da Pele	Principal Investigator
Felipe Pinho, MD	EMS	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medcin instituto da Pele		Osasco	São Paulo	060323-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D004485	Eczema
D003872	Dermatitis
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D012873	Skin Diseases, Genetic

Browse Leaves

Not provided

Browse Branches

Not provided