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Atralin Gel for the Treatment of Rosacea

This study has been terminated.
(Due to slow recruitment and sponsor request study ended early)
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Lisa E. Maier, University of Michigan
ClinicalTrials.gov Identifier:
NCT01125930
First received: May 13, 2010
Last updated: July 15, 2014
Last verified: July 2014
Results First Received: January 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Rosacea
Interventions: Drug: vehicle gel
Drug: Atralin gel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vehicle Gel Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin Gel Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.

Participant Flow:   Overall Study
    Vehicle Gel     Atralin Gel  
STARTED     22     46  
COMPLETED     21     36  
NOT COMPLETED     1     10  
Adverse Event                 0                 1  
Withdrawal by Subject                 1                 6  
Protocol Violation                 0                 1  
Lost to Follow-up                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vehicle Gel Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin Gel Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Total Total of all reporting groups

Baseline Measures
    Vehicle Gel     Atralin Gel     Total  
Number of Participants  
[units: participants]
  22     46     68  
Age  
[units: years]
Mean ± Standard Deviation
  55.00  ± 11.24     56.09  ± 11.58     55.74  ± 11.39  
Gender  
[units: participants]
     
Female     15     39     54  
Male     7     7     14  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian, European descent     22     43     65  
Caucasian, non-European descent     0     2     2  
Middle Eastern     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     22     46     68  



  Outcome Measures
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1.  Primary:   Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)   [ Time Frame: 24 weeks ]

2.  Primary:   Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia   [ Time Frame: 24 weeks ]

3.  Primary:   Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema   [ Time Frame: 24 weeks ]

4.  Primary:   Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin   [ Time Frame: 24 weeks ]

5.  Primary:   Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing   [ Time Frame: 24 weeks ]

6.  Primary:   Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning   [ Time Frame: 24 weeks ]

7.  Primary:   Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging   [ Time Frame: 24 weeks ]

8.  Primary:   Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product   [ Time Frame: 24 weeks ]

9.  Secondary:   Quality of Life   [ Time Frame: 2, 6, 12, 18, 24 weeks ]

10.  Secondary:   Photodamage   [ Time Frame: 24 weeks ]

11.  Secondary:   Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea   [ Time Frame: 2, 6, 12, 18 and 24 weeks ]

12.  Secondary:   Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea   [ Time Frame: 2, 6, 12, 18 and 24 weeks ]

13.  Secondary:   Signs of Other Rosacea Subtypes: Papulopustular   [ Time Frame: 2, 6, 12, 18, 24 weeks ]

14.  Secondary:   Molecular Markers of Inflammation   [ Time Frame: 24 weeks ]

15.  Secondary:   Molecular Evidence of Photodamage   [ Time Frame: 24 weeks ]

16.  Secondary:   Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)   [ Time Frame: 2, 6, 12, 18 weeks ]

17.  Secondary:   Severity of Erythematotelangiectatic Signs: Telangiectasia   [ Time Frame: 2, 6, 12, 18 weeks ]

18.  Secondary:   Severity of Erythematotelangiectatic Signs: Facial Edema   [ Time Frame: 2, 6, 12, 18 weeks ]

19.  Secondary:   Severity of Erythematotelangiectatic Signs: Dryness/Irritation   [ Time Frame: 2, 6, 12, 18 weeks ]

20.  Secondary:   Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing   [ Time Frame: 2, 6, 12, 18 weeks ]

21.  Secondary:   Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning   [ Time Frame: 2, 6, 12, 18 weeks ]

22.  Secondary:   Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging   [ Time Frame: 2, 6, 12, 18 weeks ]

23.  Secondary:   Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment   [ Time Frame: 2, 6, 12, 18 weeks ]

24.  Secondary:   Skin Irritation Assessed by Facial Stinging Upon Product Application   [ Time Frame: 2, 6, 12, 18 weeks ]

25.  Secondary:   Skin Irritation Assessed by Facial Itching Upon Product Application   [ Time Frame: 2, 6, 12, 18 weeks ]

26.  Secondary:   Skin Irritation Assessed by Facial Burning Upon Product Application   [ Time Frame: 2, 6, 12, 18 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination of study due to slow recruitment and sponsor request resulted in smaller number of subjects analyzed.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Lisa Maier
Organization: University of Michigan
phone: 734-936-4192
e-mail: maierl@med.umich.edu


Publications:

Responsible Party: Lisa E. Maier, University of Michigan
ClinicalTrials.gov Identifier: NCT01125930     History of Changes
Other Study ID Numbers: Derm 616
Study First Received: May 13, 2010
Results First Received: January 28, 2014
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration