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Open Label Pilot Study of Apremilast in Treatment of Rosacea

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ClinicalTrials.gov Identifier: NCT01045551
Recruitment Status : Completed
First Posted : January 11, 2010
Results First Posted : October 4, 2016
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Julian M. Mackay-Wiggan, Columbia University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Erythematotelangiectatic Rosacea
Papulopustular Rosacea
Intervention Drug: Apremilast
Enrollment 10
Recruitment Details 10 patients recruited
Pre-assignment Details  
Arm/Group Title Apremilast 20 mg (Twice Per Day)
Hide Arm/Group Description

All subjects will receive Apremilast 20mg taken orally twice per day.

Apremilast: 20mg taken orally twice per day for 12 weeks

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Apremilast 20 mg (Twice Per Day)
Hide Arm/Group Description

All subjects will receive Apremilast 20mg taken orally twice per day.

Apremilast: 20mg taken orally twice per day for 12 weeks

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  80.0%
>=65 years
2
  20.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
7
  70.0%
Male
3
  30.0%
1.Primary Outcome
Title Change From Baseline in the Total Number of Papulopustular Lesions at Week 12
Hide Description Papule and pustule count consisted of direct measurement of the number of papules/pustules on the face. Papule and pustule count, compared between baseline and end of treatment Week 12 was calculated
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Apremilast 20 mg (Twice Per Day)
Hide Arm/Group Description:

This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.

Apremilast: 20mg taken orally twice per day for 12 weeks

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: papule count
-0.2  (25.77165)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Label Apremilast 20 mg (Twice Per Day)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments The a priori threshold for statistical significance was P<0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Physician 7 Point Global Assessment From Baseline to Week 12
Hide Description The Physician Global 7-point Assessment. Scale range: 0-7. 0 = clear, 1 = minimal, 2 = mild, 3 = mild to moderate, 4= moderate, 5= moderate to severe, 6 = severe. 0 is a better outcome, 6 is a worse outcome. No subscales were used.
Time Frame Baseline, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast 20 mg (Twice Per Day)
Hide Arm/Group Description:

All subjects will receive Apremilast 20mg taken orally twice per day.

Apremilast: 20mg taken orally twice per day for 12 weeks

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.90000  (0.99443)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg (Twice Per Day)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.09
Parameter Dispersion
Type: Standard Deviation
Value: 0.9024
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Erythema Rating Visit 8 (Week 12)
Hide Description The change in the Physician Overall Erythema Severity. Scale range 0 - 3. 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe. 0 is considered a better outcome, 3 is considered a worse outcome.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast 20 mg (Twice Per Day)
Hide Arm/Group Description:

All subjects will receive Apremilast 20mg taken orally twice per day.

Apremilast: 20mg taken orally twice per day for 12 weeks

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7000  (0.48305)
4.Secondary Outcome
Title Change From Baseline in Telangiectasia Count at Visit 8 (Week 12)
Hide Description physician count of telangiectasias on the face at visit 1 (baseline) compared to at visit 8 (week 12)
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Apremilast 20 mg (Twice Per Day)
Hide Arm/Group Description:

This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.

Apremilast: 20mg taken orally twice per day for 12 weeks

Overall Number of Participants Analyzed 10
Mean (Standard Error)
Unit of Measure: telangiectasia count
0  (0)
5.Secondary Outcome
Title Change From Visit 8 (Week 12) in Telangiectasia Count at Visit 9 (Week 16)
Hide Description [Not Specified]
Time Frame Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Apremilast 20 mg (Twice Per Day)
Hide Arm/Group Description:

This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.

Apremilast: 20mg taken orally twice per day for 12 weeks

Overall Number of Participants Analyzed 10
Mean (Standard Error)
Unit of Measure: telangiectasia count
0.2000  (0.63246)
Time Frame Adverse event data was collected for approximately 4 years.
Adverse Event Reporting Description

Adverse event determination was achieved by regular solicitation subjects at study visits, from investigator assessment, and regular laboratory testing.

In addition self-reporting by participants was encouraged.

 
Arm/Group Title Apremilast 20 mg (Twice Per Day)
Hide Arm/Group Description

All subjects will receive Apremilast 20mg taken orally twice per day.

Apremilast: 20mg taken orally twice per day for 12 weeks

The most frequently reported adverse event (AE) was infection. One patient (a 74 year old female) experienced 2 urinary tract infections during the course of the study, and another (a 63 year old female) experienced one urinary tract infection. Two patients experienced upper respiratory infections, which have previously been reported in patients taking apremilast. The second most common AE was loose stool, reported by two patients, which resolved quickly and without recurrence. All AE’s were reported as mild and no patient withdrew from the study due to AEs. No patient required dosing modification or discontinuation.

All-Cause Mortality
Apremilast 20 mg (Twice Per Day)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Apremilast 20 mg (Twice Per Day)
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Apremilast 20 mg (Twice Per Day)
Affected / at Risk (%) # Events
Total   6/10 (60.00%)    
Gastrointestinal disorders   
loose stool   2/10 (20.00%)  2
Renal and urinary disorders   
urinary tract infection   2/10 (20.00%)  3
Respiratory, thoracic and mediastinal disorders   
upper respiratory infection   2/10 (20.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Julian Mackay-Wiggan, MD, MS
Organization: Columbia University Medical Center
Phone: 212-305-6953
Responsible Party: Julian M. Mackay-Wiggan, Columbia University
ClinicalTrials.gov Identifier: NCT01045551     History of Changes
Other Study ID Numbers: AAAE1745
AP-ROS-PI 0033 ( Other Identifier: Celgene )
First Submitted: January 7, 2010
First Posted: January 11, 2010
Results First Submitted: July 30, 2015
Results First Posted: October 4, 2016
Last Update Posted: December 13, 2016