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Apremilast in the Treatment of Moderate to Severe Acne

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ClinicalTrials.gov Identifier: NCT01074502
Recruitment Status : Terminated (lack of funding due to Celgene administrative decision)
First Posted : February 24, 2010
Results First Posted : March 12, 2012
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne
Intervention Drug: apremilast
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Apremilast
Hide Arm/Group Description apremilast 20 mgs twice a day for 12 weeks
Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Apremilast
Hide Arm/Group Description apremilast 20 mgs twice a day for 12 weeks
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Percentage of Patients With a Success Rate (Based on the Researcher's Global Assessment (RGA) Sum of Clear (0) or Almost Clear (1))
Hide Description RGA measures the severity of acne. The scale goes from 0-4. 0 will be better and 4 will be worse. Scores can only be whole numbers (0,1,2,3,4)ordinal.
Time Frame Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
small number of subjects to analyze
Arm/Group Title Apremilast
Hide Arm/Group Description:
apremilast 20 mgs twice a day for 12 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Percentage of Patients With a Minimum 2-grade Improvement in the Researcher Global Assessment (RGA) From Baseline to Week 12.
Hide Description RGA measures the severity of acne. The scale goes from 0 (better)to 4 (worse). Score can only be whole numbers, ordinal.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
small number of subjects to be analyzed
Arm/Group Title Apremilast
Hide Arm/Group Description:
apremilast 20 mgs twice a day for 12 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Mean Percentage Change From Baseline in Individual Lesion Counts (Total, Inflammatory, Non-inflammatory) at Week 12
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast
Hide Arm/Group Description:
apremilast 20 mgs twice a day for 12 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Percentage of Patients Achieving a Clear or Almost Clear PGA at 16 Weeks
Hide Description [Not Specified]
Time Frame Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast
Hide Arm/Group Description:
apremilast 20 mgs twice a day for 12 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title The Absolute Change in Lesion Counts (Total, Inflammatory, Non-inflammatory) From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline to12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast
Hide Arm/Group Description:
apremilast 20 mgs twice a day for 12 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Safety of Apremilast 20 Mgs BID for 12 Weeks Will be Assessed by Evaluating Adverse Events (AEs), Vital Signs, Laboratory Evaluations and Withdrawals From the Study
Hide Description Number of participants with adverse events
Time Frame Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast
Hide Arm/Group Description:
apremilast 20 mgs twice a day for 12 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apremilast
Hide Arm/Group Description apremilast 20 mgs twice a day for 12 weeks
All-Cause Mortality
Apremilast
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Apremilast
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apremilast
Affected / at Risk (%)
Total   0/3 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aida Lugo-Somolinos MD-PI
Organization: UNC Chapel Hill
Phone: 919-843-9447
EMail: alugosom@med.unc.edu
Layout table for additonal information
Responsible Party: Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01074502     History of Changes
Other Study ID Numbers: CELG0001
First Submitted: February 22, 2010
First Posted: February 24, 2010
Results First Submitted: October 6, 2011
Results First Posted: March 12, 2012
Last Update Posted: March 13, 2017