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Effects of PRK 124 Lotion in Acne Rosacea

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ClinicalTrials.gov Identifier: NCT00580723
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : December 10, 2013
Last Update Posted : January 17, 2014
Sponsor:
Collaborator:
SenetekPLC
Information provided by (Responsible Party):
Christopher Zachary, University of California, Irvine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Rosacea
Intervention Other: PRK 124
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topical PRK 124
Hide Arm/Group Description Topical PRK 124 (Pyratine-6)(0.125%)
Period Title: Overall Study
Started 24
Completed 16
Not Completed 8
Reason Not Completed
Did not want to participate in extension             3
Lost to Follow-up             5
Arm/Group Title Topical PRK 124
Hide Arm/Group Description Topical PRK 124 (Pyratine-6)(0.125%)
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
  91.7%
>=65 years
2
   8.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
51  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
18
  75.0%
Male
6
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Erythema Severity
Hide Description Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean erythema severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.
Time Frame Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.
Arm/Group Title Topical PRK 124
Hide Arm/Group Description:
Topical PRK 124 (Pyratine-6)(0.125%)
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Erythema percent improvement
44.53  (0.68)
2.Primary Outcome
Title Inflammatory Lesion Count
Hide Description Lesion counts were numerically summed for each patient at each encounter, and the average lesion count was calculated from all continuing 16 subjects at each visit, for a total of 8 visits. Percent improvement (reduction in lesion number) was assessed by comparing the average number of lesions at week 48 to the average number of lesions assessed at baseline.
Time Frame Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.
Arm/Group Title Topical PRK 124
Hide Arm/Group Description:
Topical PRK 124 (Pyratine-6)(0.125%)
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Percent change in number of lesions
89  (0.58)
3.Primary Outcome
Title Telangiectasia Severity
Hide Description Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean telangiectasia severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.
Time Frame Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Hide Outcome Measure Data
Hide Analysis Population Description
We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.
Arm/Group Title Topical PRK 124
Hide Arm/Group Description:
Topical PRK 124 (Pyratine-6)(0.125%)
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Telangiectasia percent improvement
27.88  (0.62)
4.Secondary Outcome
Title Skin Tolerance
Hide Description [Not Specified]
Time Frame Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Skin Photodamage
Hide Description [Not Specified]
Time Frame Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Transepidermal Water Loss (TEWL)
Hide Description [Not Specified]
Time Frame Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Cosmetic Acceptability
Hide Description [Not Specified]
Time Frame Baseline, Weeks 1, 4, 8, 12, 24, 36, 48
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topical PRK 124
Hide Arm/Group Description Topical PRK 124 (Pyratine-6)(0.125%)
All-Cause Mortality
Topical PRK 124
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Topical PRK 124
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Topical PRK 124
Affected / at Risk (%)
Total   0/24 (0.00%) 
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: Brian Swasdibutra, Clinical Research Coordinator
Organization: University of California, Irvine
Phone: 9498247103
EMail: bswasdib@uci.edu
Layout table for additonal information
Responsible Party: Christopher Zachary, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00580723     History of Changes
Other Study ID Numbers: 2006-5307
Contract SPLC-41239 ( Other Identifier: University of California, Irvine )
First Submitted: December 21, 2007
First Posted: December 27, 2007
Results First Submitted: March 18, 2013
Results First Posted: December 10, 2013
Last Update Posted: January 17, 2014