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Study of Apremilast in Atopic or Contact Dermatitis

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ClinicalTrials.gov Identifier: NCT00931242
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : December 20, 2010
Last Update Posted : December 20, 2010
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Tufts Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atopic Dermatitis
Allergic Contact Dermatitis
Intervention Drug: Apremilast
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Apremilast Screen Failures
Hide Arm/Group Description Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD. Patients who were screened but failed to meet inclusion criteria for the study
Period Title: Overall Study
Started 10 2
Completed 5 0
Not Completed 5 2
Arm/Group Title Apremilast Screen Failures Total
Hide Arm/Group Description Apremilast is being evaluated at daily doses of 20 mg PO (by mouth) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type atopic dermatitis or allergic contact dermatitis. Subjects that were screened but failed to meet inclusion criteria for the study. Total of all reporting groups
Overall Number of Baseline Participants 10 2 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 2 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  80.0%
2
 100.0%
10
  83.3%
>=65 years
2
  20.0%
0
   0.0%
2
  16.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 2 participants 12 participants
43.3  (14.2442971) 53.4  (4.5) 45  (13.0384048)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 2 participants 12 participants
Female
5
  50.0%
2
 100.0%
7
  58.3%
Male
5
  50.0%
0
   0.0%
5
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 2 participants 12 participants
10 2 12
1.Primary Outcome
Title Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points
Hide Description Improvement in IGA (Investigator Global Assessment) by two or more points on a five point scale, with 0 being no disease activity and 5 being maximum disease activity, at week 12
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast
Hide Arm/Group Description:
Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0
Hide Description EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast
Hide Arm/Group Description:
Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
1
3.Secondary Outcome
Title Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0
Hide Description EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast
Hide Arm/Group Description:
Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
2
Time Frame 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apremilast
Hide Arm/Group Description Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
All-Cause Mortality
Apremilast
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Apremilast
Affected / at Risk (%) # Events
Total   1/12 (8.33%)    
Infections and infestations   
Sepsis 2nd to Atopic Dermatitis * [1]  1/12 (8.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
This patient was in the screening phase of the trial and never received study medication. The subject was not eligible to enroll in trial due to the infection and flare of dermatitis.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Apremilast
Affected / at Risk (%) # Events
Total   9/12 (75.00%)    
Blood and lymphatic system disorders   
b12 deficiency  [1]  1/12 (8.33%)  1
Cardiac disorders   
asymptomatic sinus arrythmia per EKG  [2]  1/12 (8.33%)  1
Eye disorders   
Conjunctivitis  [3]  1/12 (8.33%)  1
ectropion  [3]  1/12 (8.33%)  1
atopic blepharoconjunctivitis  [3]  1/12 (8.33%)  1
meibomian gland dysfunction  [4]  1/12 (8.33%)  1
Gastrointestinal disorders   
Nausea  [3]  2/12 (16.67%)  2
GI upset  [3]  1/12 (8.33%)  1
soft stool  [3]  1/12 (8.33%)  1
flatulence  [3]  1/12 (8.33%)  1
increase in number of stools  [4]  1/12 (8.33%)  1
diverticulosis  [5]  1/12 (8.33%)  1
internal hemorrhoids  [5]  1/12 (8.33%)  1
Infections and infestations   
upper respiratory infection  [3]  2/12 (16.67%)  2
Musculoskeletal and connective tissue disorders   
foot fracture after mechanical fall *  1/12 (8.33%)  1
lower back pain 2nd to motor vehicle accident (minor)  [4]  1/12 (8.33%)  1
Nervous system disorders   
Headache  [3]  2/12 (16.67%)  2
rigors  [3]  1/12 (8.33%)  1
insomnia  [3]  1/12 (8.33%)  1
myalgias  [4]  1/12 (8.33%)  1
chills  [4]  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
Burn  [3]  1/12 (8.33%)  1
dermatitis flare  [3]  4/12 (33.33%)  4
seborrheic dermatitis  [3]  1/12 (8.33%)  1
facial irritation from ketoconazole  [3]  1/12 (8.33%)  1
hair dye allergy  [4]  1/12 (8.33%)  1
scraped shin from mechanical injury  [4]  1/12 (8.33%)  1
nodules in breasts  [6]  1/12 (8.33%)  1
MSSA skin infection  [4]  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
pcp screening
[2]
routine EKG
[3]
routine questioning at visit
[4]
routine questioning at visits
[5]
screening colonoscopy
[6]
physical examination (routine)
This was a small, single-arm open-label study with no placebo or comparison group to serve as a control.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alice B Gottlieb, MD, PhD
Organization: Tufts Medical Center
Phone: 617 636 4802
EMail: agottlieb@tuftsmedicalcenter.org
Publications:
Layout table for additonal information
Responsible Party: Alice B. Gottlieb, MD, PhD, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00931242     History of Changes
Other Study ID Numbers: AD / CD
AP-ECZ-PI-0030 ( Other Grant/Funding Number: Celgene )
First Submitted: June 30, 2009
First Posted: July 2, 2009
Results First Submitted: October 28, 2010
Results First Posted: December 20, 2010
Last Update Posted: December 20, 2010