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Topical Roflumilast in Adults With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01856764
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : July 7, 2015
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: 0.5% Roflumilast Cream
Drug: Vehicle Cream
Enrollment 40
Recruitment Details Participants took part in the study at 3 centers in Germany from 10 June 2013 to 18 March 2014.
Pre-assignment Details Participants with a historical diagnosis of Atopic Dermatitis were enrolled in 1 of 2 twice daily (BID) treatment groups.
Arm/Group Title 0.5% Roflumilast Cream Vehicle Cream
Hide Arm/Group Description Roflumilast 0.5%, cream, topically, twice daily for up to 15 days. Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title 0.5% Roflumilast Cream Vehicle Cream Total
Hide Arm/Group Description Roflumilast 0.5%, cream, topically, twice daily for up to 15 days. Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
Full Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
32.7  (11.50) 36.5  (9.65) 34.6  (10.66)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
9
  45.0%
11
  55.0%
20
  50.0%
Male
11
  55.0%
9
  45.0%
20
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
20
 100.0%
20
 100.0%
40
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 20 participants 20 participants 40 participants
20 20 40
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 20 participants 20 participants 40 participants
177.3  (9.27) 174.9  (10.13) 176.1  (9.66)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 20 participants 20 participants 40 participants
81.72  (21.757) 78.31  (12.965) 80.02  (17.762)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 20 participants 20 participants 40 participants
25.65  (5.007) 25.59  (3.477) 25.62  (4.255)
Smoking Classificaiton  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Never smoked 5 8 13
Current smoker 10 9 19
Ex-Smoker 5 3 8
Female Reproductive Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Postmenopausal 0 0 0
Surgically sterile 0 0 0
Female of childbearing potential 9 11 20
N/A (male participant) 11 9 20
Baseline Modified Local SCORing Atopic Dermatitis (SCORAD)  
Mean (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 20 participants 20 participants 40 participants
5.60
(4.0 to 8.0)
5.85
(4.0 to 8.0)
5.725
(4.0 to 8.0)
Baseline Transepidermal Water Loss (TEWL) Mean  
Mean (Full Range)
Unit of measure:  G/m^2/hr
Number Analyzed 20 participants 20 participants 40 participants
41.47
(17.8 to 69.8)
41.57
(17.8 to 63.3)
41.52
(17.8 to 69.8)
Baseline Participant Assessment of Pruritis  
Mean (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 20 participants 20 participants 40 participants
5.05
(0.0 to 9.0)
5.00
(2.0 to 10.0)
5.025
(0.0 to 10.0)
1.Primary Outcome
Title Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD)
Hide Description Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity.
Time Frame Baseline and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.
Arm/Group Title 0.5% Roflumilast Cream Vehicle Cream
Hide Arm/Group Description:
Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
Overall Number of Participants Analyzed 19 20
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.30  (0.354) -1.75  (0.347)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.5% Roflumilast Cream, Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.276
Comments Mixed Model Repeated Measures (MMRM) Model: SCORAD change from baseline = treatment + visit + treatment by visit interaction + baseline SCORAD score
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.5542 to 0.4574
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.496
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values
Hide Description Diffusion of water through the skin is measured using a Tewameter. At each visit, 3 measurements are taken per treatment area (at 3 different areas of the target lesion). The TEWL value at each visit is the average of these measurements.
Time Frame Baseline and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.
Arm/Group Title 0.5% Roflumilast Cream Vehicle Cream
Hide Arm/Group Description:
Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
Overall Number of Participants Analyzed 19 20
Least Squares Mean (Standard Error)
Unit of Measure: g/m^2/hr
-18.60  (2.467) -12.69  (2.417)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.5% Roflumilast Cream, Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments MMRM model: TEWL change from baseline = treatment + visit + treatment by visit interaction + baseline TEWL score
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.91
Confidence Interval (2-Sided) 95%
-12.9134 to 1.0835
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.454
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Day 15 in Participants' Assessment of Pruritus
Hide Description Severity of pruritus is assessed by the participants and recorded on a numeric scale ranging from 0 to 10, where 0 indicates the absence of the symptoms and 10 indicates the most severe symptoms.
Time Frame Baseline and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.
Arm/Group Title 0.5% Roflumilast Cream Vehicle Cream
Hide Arm/Group Description:
Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
Overall Number of Participants Analyzed 19 20
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-3.05  (0.426) -1.50  (0.417)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.5% Roflumilast Cream, Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments MMRM model: Assessment of Pruritus change from baseline = treatment + visit + treatment by visit interaction + baseline Assessment of Pruritus score
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.56
Confidence Interval (2-Sided) 95%
-2.7656 to -0.3492
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.596
Estimation Comments [Not Specified]
Time Frame From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22)
Adverse Event Reporting Description The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment
 
Arm/Group Title 0.5% Roflumilast Cream Vehicle Cream
Hide Arm/Group Description Roflumilast 0.5%, cream, topically, twice daily for up to 15 days. Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
All-Cause Mortality
0.5% Roflumilast Cream Vehicle Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
0.5% Roflumilast Cream Vehicle Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0.5% Roflumilast Cream Vehicle Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/20 (25.00%)      3/20 (15.00%)    
General disorders     
Application Site Pain  1  1/20 (5.00%)  1 1/20 (5.00%)  1
Infections and infestations     
Nasopharyngitis  1  3/20 (15.00%)  3 0/20 (0.00%)  0
Investigations     
Gamma-glutamyltransferase increased  1  1/20 (5.00%)  1 0/20 (0.00%)  0
Alanine aminotransferase increased  1  1/20 (5.00%)  1 0/20 (0.00%)  0
Red blood cells urine  1  0/20 (0.00%)  0 1/20 (5.00%)  1
Blood creatine phosphokinase increased  1  0/20 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/20 (5.00%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: AstraZeneca Clinical Study Information Center
Organization: AstraZeneca
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01856764    
Other Study ID Numbers: ROF-DERM_203
2012-003000-12 ( EudraCT Number )
U1111-1133-6455 ( Registry Identifier: UTN (WHO) )
First Submitted: May 14, 2013
First Posted: May 17, 2013
Results First Submitted: March 11, 2015
Results First Posted: July 7, 2015
Last Update Posted: February 1, 2017