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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2013 by EMS.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: November 29, 2010
Last updated: March 1, 2013
Last verified: March 2013
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
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

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

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

Contact: Flavia Addor 5511 3681 6362

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

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, Atopic

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Eczematous
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Allergic Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Dermatologic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 26, 2016