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Preliminary Report on a Clinical Trial of Pro-Oxy (Oxyrich)

in the treatment of ACNE VULGARIS

There were 50 patients including one patient with one follow-up only that was included in the analysis.
The mean age of the population was 20±2.15 years, majority of who females, single / not married and college students.
The mean age of acne onset was 16±3.84 years with mean duration of the condition of 3.56±2.56 years.
The details of the patients’ characteristics are shown in Table 1.

Table 1. Characteristics of Patients in the Study

Characteristics	mean	SD
Age (years)	20	2.15
Age of Onset of Acne (years)	16	3.84
Duration of Acne (years)	3.56	2.56
	No.	%
Gender Male Females Total	16 34 50	32.0 68.0 100
Civil Status Single Married Total	49 1 50	98.0 2.0 100
Highest Educational Attainment High School College Not Indicated Total	3 46 1 50	6.0 92.0 2.0 100
Occupation Nurse Student Elevator Operator Hospital Aide Janitor Total	1 45 2 1 1 50	2.0 90.0 4.0 2.0 2.0 100

The assessments of Non-Inflamed Open Comedone Lesions are shown in Table 2.1.
There was significant increase in the lesions at the forehead on the 4th and 8th week.
However, on the 12th week there were significant decrease observed. There were also significant decrease in the number of lesions
on the chin and nose areas on the 12th week observation. The overall evaluation of the lesions regardless of the area
showed increase on the 4th and 8th week but not statistically significant. On the 12th week however, significant drop was observed.

Table 2.1. Assessment of Non-Inflamed Lesion Counts by Observation Periods
Open Comedones

Lesion /
Site

Observation Periods

Week 4 (n=50

Week 8 (n=49)

Week 12 (n=49)

mean

Mean

mean

Forehead
     Pre-treatment
     Follow-up
     Difference
p-value

1.28
4.12
2.84

2.37
10.19
10.60

1.31
2.65
1.35

2.39
3.07
3.85

1.31
0.29
1.02

2.39
0.79
2.46

0.035 *

0.022 *

0.007 **

Right Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

2.12
3.24
1.12

3.73
5.40
6.96

2.04
2.35
0.31

3.73
3.34
5.04

2.16
1.43
0.74

3.76
3.57
3.75

0.395 ns

0.405 ns

0.147 ns

Left Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

2.36
2.04
0.32

5.18
4.01
6.64

2.39
1.31
1.08

5.23
2.62
5.93

2.41
0.90
1.51

5.22
3.10
5.33

0.978 ns

0.402 ns

0.078 ns

Chin
     Pre-treatment
     Follow-up
     Difference
p-value

1.24
0.66
0.58

2.72
1.49
3.04

1.27
0.86
0.41

2.75
2.58
3.71

1.27
0.24
1.02

2.75
0.99
2.94

0.241 ns

0.354 ns

0.018 *

Nose
     Pre-treatment
     Follow-up
     Difference
p-value

0.44
0.36
0.08

1.43
1.12
1.79

0.45
0.12
0.33

1.44
0.33
1.51

0.45
0.04
0.41

1.44
0.20
1.47

0.858 ns

0.127 ns

0.026 *

All Lesions
     Pre-treatment
     Follow-up
     Difference
p-value

7.44
10.42
2.98

9.56
14.06
17.89

7.45
7.29
0.16

9.66
7.01
12.61

7.59
2.90
4.69

9.60
7.27
8.69

0.162 ns

0.484 ns

0.000 ***

The Non-Inflamed Closed Comedone Lesion counts generally decreased in all areas and all observation periods.
However, statistical significant was observed in all areas on week 8 except in Chin and Nose.
On week 12, statistical significant was observed on Forehead,
Right Cheek areas and in the assessment of the lesions regardless of the area. as shown in Table 2.2.

Table 2.2. Assessment of Non-Inflamed Lesion Counts by Observation Periods
Closed Comedones

Lesion /
Site

Observation Periods

Week 4 (n=50)

Week 8 (n=49)

Week 12 (n=49)

mean

Mean

Forehead
     Pre-treatment
     Follow-up
     Difference
p-value

9.38
6.98
2.40

12.59
9.57
14.54

9.55
5.41
4.14

12.66
5.85
13.04

9.57
2.88
6.69

12.65
4.17
12.66

0.119 ns

0.050 *

0.000 ***

Right Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

1.98
0.82
1.16

4.13
2.27
4.85

2.02
0.51
1.51

4.17
1.37
4.01

1.96
0.08
1.88

4.17
0.34
4.22

0.121 ns

0.012 *

0.002 **

Left Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

0.94
0.62
0.32

3.15
1.62
3.70

0.96
0.08
0.88

3.18
0.45
3.23

0.96
0.41
0.55

3.18
1.72
3.40

0.962 ns

0.041 *

0.423 ns

Chin
     Pre-treatment
     Follow-up
     Difference
p-value

0.36
0.64
0.28

1.54
3.03
3.11

0.37
0.41
0.04

1.55
1.47
2.21

0.37
0.55
0.18

1.55
2.25
2.57

0.598 ns

0.809 ns

0.932 ns

Nose
     Pre-treatment
     Follow-up
     Difference
p-value

0.96
0.66
0.30

2.18
1.45
2.42

0.98
0.73
0.25

2.19
1.90
2.98

0.98
0.37
0.61

2.19
1.04
2.33

0.377 ns

0.471 ns

0.067 ns

All Lesions
     Pre-treatment
     Follow-up
     Difference
p-value

13.62
9.72
3.90

15.03
10.35
18.04

13.88
7.14
6.74

15.08
6.45
16.24

13.84
4.22
9.61

15.11
6.06
15.05

0.157 ns

0.010 **

0.000 ***

The assessments of Non-Inflamed Lesions regardless of whether open or closed comedones are shown in Table 2.3.
Generally lesions in all sites decreased but statistical significance was observed on the 12th week except on the Chin area.

Table 2.3. Assessment of Total Non-Inflamed Lesion Counts by Observation Periods

Lesion /
Site

Observation Periods

Week 4 (n=50)

Week 8 (n=49)

Week 12 (n=49)

mean

Mean

mean

Forehead
     Pre-treatment
     Follow-up
     Difference
p-value

10.66
11.10
0.44

12.53
17.34
21.42

10.86
8.06
2.80

12.58
7.06
13.45

10.88
3.16
7.71

12.56
4.23
12.86

0.487 ns

0.244 ns

0.000 ***

Right Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

4.10
4.06
0.04

6.01
6.32
8.69

4.06
2.86
1.20

6.07
3.82
6.56

4.12
1.51
2.61

6.07
3.62
4.71

0.925 ns

0.491 ns

0.000 ***

Left Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

3.30
2.66
0.64

6.43
4.27
7.85

3.35
1.39
1.96

6.49
2.78
7.29

3.37
1.31
2.06

6.48
3.44
6.01

0.926 ns

0.130 ns

0.030 *

Chin
     Pre-treatment
     Follow-up
     Difference
p-value

1.60
1.30
0.30

3.74
3.74
5.20

1.63
1.27
0.37

3.77
3.77
5.47

1.63
0.80
0.84

3.77
2.40
4.26

0.537 ns

0.453 ns

0.149 ns

Nose
     Pre-treatment
     Follow-up
     Difference
p-value

1.40
1.02
0.38

2.57
1.90
2.93

1.43
0.86
0.57

2.59
1.90
3.31

1.43
0.41
1.02

2.59
1.08
2.74

0.345 ns

0.250 ns

0.012 *

All Lesions
     Pre-treatment
     Follow-up
     Difference
p-value

21.06
20.14
0.92

19.08
22.33
30.69

21.33
14.43
6.90

19.18
10.97
23.14

21.43
7.18
14.25

19.10
9.78
18.25

0.594 ns

0.065 ns

0.000 ***

A highly significant decrease in papules was observed in all sites and observation periods as shown in Table 3.1.

Table 3.1. Assessment of Inflamed Lesion Counts by Observation Periods
(Papules)

Lesion /
Site

Observation Periods

Week 4 (n=50)

Week 8 (n=49)

Week 12 (n=49)

mean

Mean

mean

Forehead
     Pre-treatment
     Follow-up
     Difference
p-value

5.42
3.16
2.26

5.81
3.45
4.90

5.53
2.82
2.71

5.82
3.15
5.59

5.45
2.59
2.86

5.87
2.89
6.68

0.002 **

0.001 ***

0.011 *

Right Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

6.80
3.32
3.48

6.00
4.51
6.67

6.92
4.82
2.10

6.00
6.70
7.87

6.69
3.51
3.18

6.02
4.05
6.04

0.000 ***

0.002 **

0.001 ***

Left Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

7.96
4.40
3.56

5.69
5.65
7.28

8.12
4.06
4.06

5.63
5.55
6.14

7.98
2.90
5.08

5.75
3.79
5.91

0.000 ***

0.001 ***

Chin
     Pre-treatment
     Follow-up
     Difference
p-value

3.86
1.58
2.28

3.99
2.55
3.90

3.94
1.39
2.55

3.99
2.19
4.18

3.94
1.45
2.49

3.99
2.13
4.13

0.000 ***

Nose
     Pre-treatment
     Follow-up
     Difference
p-value

2.20
0.30
1.90

4.06
0.81
4.25

2.24
0.37
1.88

4.09
0.67
4.17

2.24
0.63
1.61

4.09
1.55
4.21

0.002 **

0.008 **

All Lesions
     Pre-treatment
     Follow-up
     Difference
p-value

26.24
12.76
13.48

14.09
11.46
15.08

26.76
13.47
13.29

13.75
12.95
14.30

26.31
11.08
15.22

14.23
9.70
15.01

0.000 ***

Generally, a decrease was observed in the pustular lesion counts in all sites,
but statistical significance was obtained only on week 8 of Forehead; from week 4 to week 12 of Left Cheek; and week 4 and week 8 of Chin.
Assessment of all Pustules Lesions showed significant decrease from week 4 to week 8, Table 3.2.

Table 3.2. Assessment of Inflamed Lesion Counts by Observation Periods
(Pustules)

Lesion /
Site

Observation Periods

Week 4 (n=50)

Week 8 (n=49)

Week 12 (n=49)

mean

Mean

mean

Forehead
     Pre-treatment
     Follow-up
     Difference
p-value

0.62
0.22
0.40

1.67
0.58
1.61

0.63
0.10
0.53

1.68
0.42
1.57

0.63
0.51
0.12

1.68
1.31
1.83

0.137 ns

0.018 *

0.775 ns

Right Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

0.50
0.80
0.30

1.31
1.85
1.80

0.51
0.53
0.02

1.33
1.29
1.39

0.49
0.16
0.33

1.33
0.43
1.41

0.569 ns

0.748 ns

0.144 ns

Left Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

0.66
0.24
0.42

1.48
0.69
1.34

0.67
0.16
0.51

1.49
0.62
1.52

0.63
0.12
0.51

1.48
0.73
1.92

0.027 *

0.020 *

0.004 **

Chin
     Pre-treatment
     Follow-up
     Difference
p-value

0.66
0.24
0.42

1.69
0.92
1.42

0.67
0.41
0.27

1.70
1.57
2.34

0.67
0.14
0.53

1.70
0.46
1.62

0.041 *

0.376 ns

0.026 *

Nose
     Pre-treatment
     Follow-up
     Difference
p-value

0.34
0.22
0.12

1.47
0.93
0.75

0.35
0.08
0.27

1.48
0.34
1.54

0.35
0.27
0.08

1.48
0.97
1.41

0.301 ns

0.250 ns

0.491 ns

All Lesions
     Pre-treatment
     Follow-up
     Difference
p-value

2.78
1.72
1.06

4.11
2.81
3.50

2.84
1.29
1.55

4.13
2.37
3.35

2.78
1.20
1.57

4.15
2.02
4.30

0.013 *

0.002 **

0.016 *

A decrease in Nodule counts were observed in most sites. However statistical significant decrease was observed on week 4 and week 12 of Right Cheek.
The assessment of all Nodule lesions regardless of site showed significant decrease on week 12 as shown in Table 3.3.

Table 3.3. Assessment of Inflamed Lesion Counts by Observation Periods
(Nodules)

Lesion /
Site

Observation Periods

Week 4 (n=50)

Week 8 (n=49)

Week 12 (n=49)

mean

Forehead
     Pre-treatment
     Follow-up
     Difference
p-value

0.06
0.04
0.02

0.31
0.20
0.38

0.06
0.02
0.04

0.32
0.14
0.29

0.06
0.00
0.06

0.32
0.00
0.32

0.705 ns

0.317 ns

0.180 ns

Right Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

0.26
0.00
0.26

0.97
0.00
0.97

0.27
0.02
0.25

0.97
0.14
0.99

0.27
0.00
0.27

0.97
0.00
0.97

0.024 *

0.054 ns

0.024 *

Left Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

0.20
0.00
0.20

1.03
0.00
1.03

0.20
0.08
0.12

1.04
0.45
1.15

0.20
0.00
0.20

1.04
0.00
1.04

0.109 ns

0.588 ns

0.715 ns

Chin
     Pre-treatment
     Follow-up
     Difference
p-value

0.10
0.08
0.02

0.42
0.40
0.59

0.10
0.02
0.08

0.42
0.14
0.45

0.10
0.02
0.08

0.42
0.14
0.34

0.888 ns

0.194 ns

0.102 ns

Nose
     Pre-treatment
     Follow-up
     Difference
p-value

0.22
0.10
0.12

1.28
0.58
1.42

0.22
0.27
0.04

1.30
1.72
2.06

0.22
0.00
0.22

0.30
0.00
1.30

0.680 ns

0.854 ns

0.102 ns

All Lesions
    Pre-treatment
     Follow-up
     Difference
p-value

0.84
0.22
0.62

2.30
0.71
2.45

0.86
0.41
0.45

2.32
2.04
2.94

0.86
0.02
0.84

2.32
0.14
2.30

0.107 ns

0.062 ns

0.003 **

All Inflamed Lesions regardless of type as shown in Table 3.4 decreased significantly in all sites.

Table 3.4. Assessment of All Inflamed Lesion Counts by Observation Periods

Lesion /
Site

Observation Periods

Week 4 (n=50)

Week 8 (n=49)

Week 12 (n=49)

Mean

mean

Forehead
     Pre-treatment
     Follow-up
     Difference
p-value

6.10
3.42
2.68

6.20
3.66
5.09

6.22
2.94
3.29

6.20
3.19
5.86

6.14
3.10
3.04

6.26
3.48
7.28

0.000 ***

0.018 *

Right Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

7.56
4.12
3.44

6.41
5.61
7.13

7.69
5.37
2.33

6.41
7.41
8.08

7.45
3.67
3.78

6.43
4.11
6.55

0.000 ***

0.005 **

0.000 ***

Left Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

8.82
4.64
4.18

6.19
5.69
7.21

9.00
4.31
4.69

6.12
5.89
5.76

8.82
3.02
5.80

6.26
4.05
6.43

0.000 ***

Chin
     Pre-treatment
     Follow-up
     Difference
p-value

4.62
1.90
2.72

4.60
3.29
4.28

4.71
1.82
2.90

4.60
3.09
5.11

4.71
1.61
3.10

4.60
2.21
4.59

0.000 ***

Nose
     Pre-treatment
     Follow-up
     Difference
p-value

2.76
0.62
2.14

5.02
1.28
4.72

2.82
0.71
2.10

5.06
1.84
4.13

2.82
0.90
1.92

5.06
2.31
5.13

0.002 **

0.001 ***

0.004 **

All Lesions
     Pre-treatment
     Follow-up
     Difference
p-value

29.86
14.70
15.16

15.72
13.28
15.04

30.45
15.16
15.29

15.32
14.41
13.95

29.94
12.31
17.63

15.87
10.63
17.08

0.000 ***

The overall assessments of lesions regardless of whether Inflamed or Non-Inflamed are presented in Table 4.
Highly significant decrease in the lesion counts were observed in all sites and all observation periods.

Table 4. Assessment of All Lesions Counts by Observation Periods

Lesion /
Site

Observation Periods

Week 4 (n=50)

Week 8 (n=49)

Week 12 (n=49)

Mean

mean

Mean

Forehead
     Pre-treatment
     Follow-up
     Difference
p-value

16.76
14.52
2.24

13.94
17.77
22.61

17.08
11.00
6.08

13.90
8.11
15.35

17.02
6.27
10.76

13.96
5.35
15.66

0.035 *

0.016 ns

0.000 ***

Right Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

11.66
8.18
3.48

8.10
8.11
11.11

11.76
8.22
3.53

8.16
7.86
8.57

11.57
5.18
6.39

8.16
5.38
8.09

0.017 *

0.002 **

0.000 ***

Left Cheek
     Pre-treatment
     Follow-up
     Difference
p-value

12.12
7.30
4.82

9.21
7.27
11.43

12.35
5.69
6.65

9.16
5.99
10.07

12.18
4.33
7.86

9.30
5.19
9.49

0.001 ***

0.000 ***

Chin
     Pre-treatment
     Follow-up
     Difference
p-value

6.22
3.20
3.02

5.44
5.10
7.11

6.35
3.08
3.27

5.42
5.00
6.95

6.35
2.41
3.94

5.42
3.18
6.00

0.002 **

0.000 ***

Nose
     Pre-treatment
     Follow-up
     Difference
p-value

4.16
1.62
2.54

5.22
2.35
4.80

4.24
1.53
2.71

5.24
2.67
3.88

4.24
1.31
2.94

5.24
2.52
4.81

0.001 ***

0.000 ***

All Lesions
     Pre-treatment
     Follow-up
     Difference
p-value

50.92
34.84
16.08

22.99
26.53
35.19

51.78
29.59
22.18

22.41
18.62
24.57

51.37
19.49
31.88

23.01
14.57
23.74

0.000 ***

There was significant improvement in the Investigator’s Global Assessment (IGA) of effects of the treatment in all observation periods. A significant decrease in severity of the conditions was presented in Table 5. On the 12th week none of the patients showed severe lesions. Only 1 had moderate condition while the rest have mild to clear lesions.

Table 5. Investigator’s Global Assessment of Treatment

Investigator’s Global Assessment	Observation Periods
	Pre-Treatment		Follow-Up
	No.	%	No.	%
4 weeks Clear Almost Clear Mild Moderate Severe Total p-value	0 1 29 15 5 50	- 2.0 58.0 30.0 10.0 100	0 8 34 7 1 50	- 16.0 68.0 14.0 2.0 100
	0.000 ***
8 weeks Clear Almost Clear Mild Moderate Severe Total p-value	0 0 29 15 5 49	- - 59.2 30.6 10.2 100	0 6 39 2 2 49	- 12.2 79.6 4.1 4.1 100
	0.000 ***
12 weeks Clear Almost Clear Mild Moderate Severe Total p-value	0 1 28 15 5 49	- 2.0 57.1 30.6 10.2 100	3 6 39 1 0 49	6.1 12.2 79.6 2.0 - 100
	0.000 ***

More than half of the patients were very satisfied with the treatment at the end of the study. The rest were satisfied as shown in the table below, Table 6.

Table 6. Patients Satisfactory Assessment of the Treatment

Assessment	No.	%
4 weeks Very Dissatisfied Dissatisfied Somewhat Satisfied Satisfied Very Satisfied Total	0 0 3 28 19 50	- - 6.0 56.0 38.0 100
8 weeks Very Dissatisfied Dissatisfied Somewhat Satisfied Satisfied Very Satisfied Total	0 0 1 27 21 49	- - 2.0 55.1 42.9 100
12 weeks Very Dissatisfied Dissatisfied Somewhat Satisfied Satisfied Very Satisfied Total	0 0 0 22 27 49	- - - 44.9 55.1 100

Data Management and Statistical Analysis

Data were electronically encoded using Dbase 3 Program. To assure accuracy of encoding, data encoded were checked manually 3 times against the Clinical Research Form (CRF). Statistical analyses were performed after editing had been done.

Only patients with at least 1 follow-up observation were included in the analysis. Continuous data were described as mean±sd and categorical data as frequency and percent distribution. To determine significant change in lesion counts and IGA, Wilcoxon Matched Pairs Signed Ranks Test was applied to the data. A p≤0.050 was considered significant.

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