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Trial record 8 of 11 for:    clemastine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01257061
Recruitment Status : Unknown
Verified March 2013 by EMS.
Recruitment status was:  Recruiting
First Posted : December 9, 2010
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
EMS

Tracking Information
First Submitted Date  ICMJE November 29, 2010
First Posted Date  ICMJE December 9, 2010
Last Update Posted Date March 4, 2013
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2010)
Reduction / improvement of signs and symptoms [ Time Frame: DAY 22 ]
The reduction of signs an symptoms will be evaluated by OSAAD index.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01257061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2010)
Adverse Events Evaluation [ Time Frame: DAY 22 ]
Adverse events will be collected and followed in order to evaluate safety and tolerability.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment
Official Title  ICMJE 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Eczema
Intervention  ICMJE
  • Drug: Group 1
    Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion
  • Drug: Group 2
    Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion
Study Arms  ICMJE
  • Experimental: Group 1
    Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g
    Intervention: Drug: Group 1
  • Active Comparator: Group 2
    Dexchlorpheniramine maleate 10 mg/g
    Intervention: Drug: Group 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 8, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01257061
Other Study ID Numbers  ICMJE DECEMS1010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EMS
Study Sponsor  ICMJE EMS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Flavia Addor, MD Medcin Instituto da Pele
Study Director: Felipe Pinho, MD EMS
PRS Account EMS
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP