Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment
Unicentric Comparing Effectiveness Superiority of to Clemastine Fumarate 1, 0 mg/g + Dexamethasone 0, 5 mg/g to Dexchlorpheniramine Maleate 10 mg/g in Eczema Treatment.
1 other identifier
interventional
310
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2012
Shorter than P25 for phase_3
1 active site
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
November 29, 2010
CompletedFirst Posted
Study publicly available on registry
December 9, 2010
CompletedStudy Start
First participant enrolled
September 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2013
CompletedJuly 7, 2020
June 1, 2020
8 months
November 29, 2010
July 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction / improvement of signs and symptoms
The reduction of signs an symptoms will be evaluated by OSAAD index.
DAY 22
Secondary Outcomes (1)
Adverse Events Evaluation
DAY 22
Study Arms (2)
Group 1
EXPERIMENTALClemastine fumarate 1,0 mg/g + dexamethasone 0,5/g
Group 2
ACTIVE COMPARATORDexchlorpheniramine maleate 10 mg/g
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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
- EMSlead
Study Sites (1)
Medcin instituto da Pele
Osasco, São Paulo, 060323-000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Flavia Addor, MD
Medcin Instituto da Pele
- STUDY DIRECTOR
Felipe Pinho, MD
EMS
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2010
First Posted
December 9, 2010
Study Start
September 6, 2012
Primary Completion
April 30, 2013
Study Completion
August 2, 2013
Last Updated
July 7, 2020
Record last verified: 2020-06