Trial Outcomes & Findings for Effects of PRK 124 Lotion in Acne Rosacea (NCT NCT00580723)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

Results posted on

2014-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	Topical PRK 124 Topical PRK 124 (Pyratine-6)(0.125%)
Overall Study STARTED	24
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Topical PRK 124 Topical PRK 124 (Pyratine-6)(0.125%)
Overall Study Did not want to participate in extension	3
Overall Study Lost to Follow-up	5

Baseline Characteristics

Effects of PRK 124 Lotion in Acne Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical PRK 124 n=24 Participants Topical PRK 124 (Pyratine-6)(0.125%)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Topical PRK 124 n=16 Participants Topical PRK 124 (Pyratine-6)(0.125%)
Erythema Severity	44.53 Erythema percent improvement Standard Deviation 0.68

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Topical PRK 124 n=16 Participants Topical PRK 124 (Pyratine-6)(0.125%)
Inflammatory Lesion Count	89 Percent change in number of lesions Standard Deviation 0.58

PRIMARY outcome

Timeframe: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Topical PRK 124 n=16 Participants Topical PRK 124 (Pyratine-6)(0.125%)
Telangiectasia Severity	27.88 Telangiectasia percent improvement Standard Deviation 0.62

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 4, 8, 12, 24, 36, 48

Outcome measures

Outcome data not reported

Adverse Events

Topical PRK 124

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian Swasdibutra, Clinical Research Coordinator

University of California, Irvine

Phone: 9498247103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place