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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01257061
First received: November 29, 2010
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Eczema
Drug: Group 1
Drug: Group 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Reduction / improvement of signs and symptoms [ Time Frame: DAY 22 ] [ Designated as safety issue: No ]
    The reduction of signs an symptoms will be evaluated by OSAAD index.


Secondary Outcome Measures:
  • Adverse Events Evaluation [ Time Frame: DAY 22 ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability.


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g
Drug: Group 1
Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion
Active Comparator: Group 2
Dexchlorpheniramine maleate 10 mg/g
Drug: Group 2
Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion

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
  Eligibility

Ages Eligible for Study:   5 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257061

Contacts
Contact: Flavia Addor 5511 3681 6362

Locations
Brazil
Medcin instituto da Pele Recruiting
Osasco, São Paulo, Brazil, 060323-000
Contact: Flavia Addor    5511 3681 6362      
Sponsors and Collaborators
EMS
Investigators
Principal Investigator: Flavia Addor, MD Medcin Instituto da Pele
Study Director: Felipe Pinho, MD EMS
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01257061     History of Changes
Other Study ID Numbers: DECEMS1010
Study First Received: November 29, 2010
Last Updated: March 1, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
Dermatitis
Dermatitis, Atopic

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Clemastine
Chlorpheniramine
Dexchlorpheniramine
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Maleic acid
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on July 26, 2014