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Effects of PRK 124 Lotion in Acne Rosacea

This study has been completed.
Sponsor:
Collaborator:
SenetekPLC
Information provided by (Responsible Party):
Christopher Zachary, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00580723
First received: December 21, 2007
Last updated: December 16, 2013
Last verified: December 2013
Results First Received: March 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acne Rosacea
Intervention: Other: PRK 124

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Topical PRK 124 Topical PRK 124 (Pyratine-6)(0.125%)

Participant Flow:   Overall Study
    Topical PRK 124  
STARTED     24  
COMPLETED     16  
NOT COMPLETED     8  
Did not want to participate in extension                 3  
Lost to Follow-up                 5  



  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.
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Reporting Groups
  Description
Topical PRK 124 Topical PRK 124 (Pyratine-6)(0.125%)

Baseline Measures
    Topical PRK 124  
Number of Participants  
[units: participants]
  24  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     22  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  51  ± 11  
Gender  
[units: participants]
 
Female     18  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     24  



  Outcome Measures
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1.  Primary:   Erythema Severity   [ Time Frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48 ]

2.  Primary:   Inflammatory Lesion Count   [ Time Frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48 ]

3.  Primary:   Telangiectasia Severity   [ Time Frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48 ]

4.  Secondary:   Skin Tolerance   [ Time Frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Skin Photodamage   [ Time Frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Transepidermal Water Loss (TEWL)   [ Time Frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Cosmetic Acceptability   [ Time Frame: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  More Information
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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:  
Name/Title: Brian Swasdibutra, Clinical Research Coordinator
Organization: University of California, Irvine
phone: 9498247103
e-mail: bswasdib@uci.edu


Publications:

Responsible Party: Christopher Zachary, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00580723     History of Changes
Other Study ID Numbers: 2006-5307, Contract SPLC-41239
Study First Received: December 21, 2007
Results First Received: March 18, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board