Clinical Trials Logo
  1. Home
  2. Atopic Dermatitis
  3. NCT01359787
  4. Details
NCT01359787 Clinical Trial

Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)

Atopic Dermatitis Clinical Trial

Official title:
Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of Mapracorat Ointment in Three Concentrations Over Max. 4 Weeks in Subjects With Atopic Dermatitis (AD)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01359787
Other study ID # 15616
Secondary ID 14034402010-0242
Status Completed
Phase Phase 2
First received May 23, 2011
Last updated January 19, 2015
Start date May 2011
Est. completion date September 2011

Study information
Verified date January 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyLatvia: State Agency of MedicinesPoland: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).

Recruitment information / eligibility
Status Completed
Enrollment 197
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Signed written informed consent

- Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria

- Willingness of subject to follow all study procedures

- Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

Exclusion Criteria:

- Pregnancy and breast-feeding

- Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results

- Clinically manifested immunosuppressive disorder or known history of malignant disease

- History of relevant drug and/or food allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Mapracorat
Daily topical application
• Vehicle without active
Daily topical application

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Eczema Area and Severity Index (EASI) Over all study visits for up to 4 weeks No
Secondary Subjects´ assessment of pruritus Subjects´ assessment of pruritus using a visual analog scale (VAS) At baseline and after 4 weeks of treatment No
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2

External Links