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.

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.

Study Overview

• Status: Completed
• Conditions: Eczema
• Intervention / Treatment: Drug: Group 1; Drug: Group 2

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
• Enrollment (Actual): 310
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Osasco, São Paulo, Brazil, 060323-000
      • Medcin Instituto Da Pele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction / improvement of signs and symptoms	The reduction of signs an symptoms will be evaluated by OSAAD index.	DAY 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Evaluation	Adverse events will be collected and followed in order to evaluate safety and tolerability.	DAY 22

Collaborators and Investigators

• Sponsor: EMS
• Investigators: Principal Investigator: Flavia Addor, MD, Medcin Instituto Da Pele

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 6, 2012
• Primary Completion (ACTUAL): April 30, 2013
• Study Completion (ACTUAL): August 2, 2013

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (ESTIMATE): December 9, 2010

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Dermatitis, Atopic; Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: DECEMS1010