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

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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
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Eczema Drug: Group 1 Drug: Group 2 Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : September 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : August 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Reduction / improvement of signs and symptoms [ Time Frame: DAY 22 ]
    The reduction of signs an symptoms will be evaluated by OSAAD index.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01257061     History of Changes
Other Study ID Numbers: DECEMS1010
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013

Keywords provided by EMS:
Dermatitis, Atopic

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Eczematous
Dexamethasone acetate
BB 1101
Maleic acid
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents