Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-29 @ 9:56 PM
Study NCT ID:
NCT01257061
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2010-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment
Sponsor:
EMS
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
• 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: