A REPORT OF CLINICAL TRIAL CONDUCTED ON Тото OINTMENT: RESULTS
Posted by JamesA total of 607 patients were seen at the beginning of the study period but 12 (1.8%) could not satisfy the inclusion criteria fully. Five hundred and ninety-five patients participated in the clinical trial, all of which were Nigerians. Their ages ranged from six years to seventy-five years (mean 13.87 ± 10.55 years) with a sex ratio M/F of 1:1, (302 males and 293 females), and a mean body mass index of 17.2 ± 5.5.
Description of skin diseases
Table 1 shows the pattern of skin disease types seen during the clinical trial. Out of the 595 patients seen, 446 (74.9%) had fungal infections while 64 (10.8%) had scabies infestation. Forty-seven (7.9%), 36 (6.1%), and 2(0.3%) patients had bacterial skin infections, acne vulgaris and dandruff, respectively. canadian pharmacy generic viagra
Table 1. PATTERN OF SKIN DISEASE TYPES
| Skin Disease Type | Number of Patients |
% Total |
| FUNGAL | ||
| (i) Tinea Capitis |
258 |
43.5 |
| (ii) Pityriasis versicolor |
129 |
21.6 |
| (iii) Tinea corporis |
21 |
3.4 |
| (iv) Tinea unguium |
13 |
2.2 |
| (v) Tinea pedis |
13 |
2.2 |
| (vi) Intertrigo |
12 |
2.0 |
| Scabies |
64 |
10.8 |
| Bacterial | ||
| (i) Septic spots |
37 |
6.2 |
| (ii) Folliculitis |
10 |
1.7 |
| Acne Vulgaris |
36 |
6.1 |
| Dandruff |
2 |
0.3 |
| Total |
595 |
100 |
The median values of disease duration are as follows:
(1) Fungal: five months (range 0.25-180 months)
(2) Bacterial: five months (range 0.25-48 months)
(3) Scabies: four months (range 0.1- 60 months)
(4) Acne vulgaris: six months (range 1.0-48.0 months)
(5) Dandruff: four months (range 3.0-9.0 months)
Description of treatment given
a) Distribution pattern: Table 2 shows the distribution pattern of patients’ vis-a-vis therapy. One hundred and ninety (31.7%) patients were placed on Toto ointment alone, 123 patients (20.6%) had Toto soap alone, and 133 patients (22.7%) were placed on sulfur ointment alone, while 149 (25.0%) patients had Toto ointment combined with Toto soap. No patient with scabies had sulfur ointment deliberately, since sulfur ointment is not known to be very active against scabies. online pharmacy prescription drugs
Table 2. DISTRIBUTION OF PATIENTS VIS-A-VIS THERAPY GIVEN
| Toto | Sulfur | Toto | Toto Ointment | ||
| Ointment | Ointment | Soap | + Soap | Total (%) | |
| Fungal | 129 (28.9) | 121 (27.1) | 107 (23.9) | 89 (19.9) | 446 (74.9) |
| Bacterial | 12 (25.5) | 7(14.9) | 10 (21.3) | 18 (38.3) | 47 (7.9) |
| Scabies | 47 (73.4) | 0(0) | 5 (7.8) | 12 (18.8) | 64 (10.8) |
| Acne v. | 1 (2.8) | 4(11.1) | 1 (2.8) | 30 (83.3) | 36 (6.1) |
| Dandruff | 1 (25) | 1 (25) | 0(0) | 0(0) | 2 (0.3) |
| Total (%) | 190 (31.7) | 133 (22.7) | 123 (20.6) | 149 (25.0) | 595 |
b) Period of treatment: The mean period of treatment for each disease to clinical success is as follows:
(i) Fungal infection: 5.8 weeks (1.0-16.0 ±
3.9)
(ii) Bacterial infection: 11.6 weeks (2.0-16.0 ± 3.8)
(Hi) Scabies: 6.1 weeks (2.0-8.0 ± 1.5)
(iv) Acne vulgaris: 3.8 weeks (2.0-15 ±
4.9)
(v) Dandruff: 3.8 weeks (4.0-6.0 ± 0.8)
Generally, the median period of usage of Toto ointment, Toto soap, combined Toto ointment and soap and sulfur ointment are five weeks (range 1-16 ± 3.9), six weeks (range 2-8 ± 1.5), six weeks (1-15 ± 4.9), and 12 weeks (range2-16 ± 3.9), respectively.
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Table 3. TREATMENT OUTCOME OF PATIENTS WITH FUNGAL SKIN INFECTIONS
|
Partial |
|||||||
| Clinical |
Clinical |
Clinical | Lost to |
Non |
Total |
||
| Failure |
Success |
Success | Indeterminable | Follow Up |
Compliance |
(%) |
|
| Toto ointment | 11 (8.5) | 7 (6.97) | 92 (71.3) | 0(0) | 10(7.8) |
7 (5.4) |
129 (28.9) |
| Sulfur ointment | 21 (1.7) |
41 (33.9) |
46 (38.7) | 3 (2.5) | 5 (4.2) |
5 (4.2) |
121 (27.1) |
| Toto soap | 15 (14.8) |
33 (38.8) |
55 (51.4) | 1 (0.9) | 0(0) |
3 (2.9) |
107 (23.9) |
| Toto ointment + toto | 6 (6.7) |
10(11.2) |
69 (77.5) | 3 (3.4) | 1 (1.1) | 0(0) |
89 (19.9) |
| OVJVJLJ
Total (%) |
53 (11.8) | 93 (20.8) 262 (58.7) | 7(1.5) | 17(3.8) |
15 (3.4) |
446 | |
c) Outcome of treatment: shows clinical photographs of patients with various common skin diseases before and after therapy with Toto products. Tables 3 through 5 show treatment outcome of patients with the skin diseases seen during the clinical trial. Out of the 129 patients with fungal skin infections treated with Toto ointment alone, 92 (71.3%) showed clinical success, while 69 (77.5%) out of 89 patients treated with combination of Toto ointment and soap showed clinical success. Only 46 (38.7%) out of 121 of patients treated with sulfur ointment alone showed clinical success. However, 55 (51.4%) of 107 patients were successfully treated with Toto soap alone. Similarly, 11 (91.6%) out of 12 patients showed clinical success in the treatment of bacterial skin infections with Toto ointment alone while 12 (66.7%) out of 18 patients were successfully treated with Toto ointment combined with soap, (Table 4). Among the patients treated for scabies (Table 5), 41 (87.2%) out of 47 were cured with Toto ointment alone, while all (12 [100%]) patients were cured with the combination of the ointment and the soap. Patients with scabies were not placed on sulfur ointment. suhagra 100
Table 4. TREATMENT OUTCOME OF PATIENTS WITH BACTERIAL SKIN INFECTIONS
| Partial | |||||||
| Clinical | Clinical | Clinical | Lost to | Non | |||
| Failure | Success |
Success |
Indeterminable |
Follow Up | Compliance | Total (%) | |
| Toto ointment |
0(0) |
0(0) |
11 (91.6) |
0(0) |
1 (8.3) | 0(0) | 12 (25.5) |
| Sulfur ointment |
0(0) |
1 (14.3) |
4(57.1) |
0(0) |
2 (28.6) | 0(0) | 7(14.9) |
| Toto soap |
0(0) |
0(0) |
10(100) |
0(0) |
0(0) | 0(0) | 10(21.3) |
| Toto ointment + soap |
0(0) |
0(0) |
12 (66.7) |
0(0) |
5 (27.7) | 1 (5.6) | 18 (38.3) |
| Total (%) |
0(0) |
1 (2.1) |
37 (78.7) |
0(0) |
8 (17.0) | 1 (2.1) | 47 |
Although few patients were seen with acne vulgaris (36) and dandruff (2), patients showed good response to Toto ointment or soap, as well to the combination of both.
Generally, there is a significant difference (better effect) in the clinical success rate of Toto products on all diseases studied, compared to the effect of sulfur ointment alone (X2 = 27.78, df = 5, p < 0.0001); likewise, the effects of Toto ointment combined with Toto soap compared with sulfur ointment alone, (X2 = 35.19 df = 5 p < 0.000001). silagra
Table 5. TREATMENT OF OUTCOME OF PATIENTS WITH SCABIES INFECTIONS
| Partial | ||||||
|
Clinical |
Clinical Clinical | Lost to |
Non |
|||
|
Failure |
Success Success |
Indeterminable |
Follow Up |
Compliance |
Total (%) |
|
| Toto ointment |
0(0) |
1 (2.1) 41 (87.2) |
0(0) |
5 (10.6) |
0(0) |
47 (73.4) |
| Sulfur ointment |
0(0) |
0(0) 1 (100) |
0(0) |
0(0) |
0(0) |
1 (20) |
| Toto soap |
0(0) |
0(0) 5(100) |
0(0) |
0(0) |
0(0) |
5 (7.8) |
| Toto ointment + toto soap |
0(0) |
0(0) 11 (100) |
0(0) |
0(0) |
0(0) |
11 (18.8) |
| Total (%) |
0(0) |
1 (1.6) 58 (90.6) |
0(0) |
5 (7.8) |
0(0) |
64 |
Comparing the overall effects of Toto soap with sulfur ointment, although the proportion of the patients that showed clinical success were 60 (39%) and 76 (54.3%), respectively, about 74 (48.1%) of the patients on Toto soap and 43 (30.7%) of the patients on sulfur ointment showed partial clinical success to all disease types studied, (X2 = 32.31,df = 5, p < 0.00001). Generally, the outcome of treatment is not affected by the duration of disease. The site of fungal lesions, however, affected the outcome. The few cases of Tinea ungium seen (13 [2.2%] ) and Tinea pedis (13 [2.2%] ) showed little improvement during the clinical trial period.
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Table 6. MEAN LABORATORY VALUES OF PATIENTS AT THE BEGINNING AND END OF STUDY
| Laboratory | Value at the Beginning of | Value at the | |
| Parameter | Study | End of Study | P-Value |
| Haematocrit | 35 + 3.2 mEq/L | 34.5 ±3.2 mEq/L | >0.05 |
| Na+ | 131.7 ± 0.6 mEq/L | 131.2 + 0.7 mEq/L | >0.05 |
| ci- | 103.1 ± 0.6 mEq/L | 103 ± 0.4 mEq/L | >0.05 |
| K+ | 3.6 ± 0.1 mEq/L | 3.5 + 0.1 mEq/L | >0.05 |
| HC03 | 26.5 ± 0.4 mEq/L | 25.3 ± 0.2 mEq/L | >0.05 |
| Urea | 35.8 ± 5.2 mEq/L 0.5 ± 0.1 mg% | 36.1 ± 3.2 mEq/L | >0.05 |
| Creatinine | 0.5 ± 0.3 mg% | >0.05 | |
| Sgot | 26 ± 0.3 iu/L | 27 ± 0.2 iu/L | >0.05 |
| Sgpt | 24 ± 0.1 iu/L | 23 + 0.3 iu/L | >0.05 |
| Total bilirubin | 0.8 ± 0.3 iu/L | 0.85 ± 0.1 iu/L | >0.05 |
| Indirect bilirubin | 0.6 ± 0.3 iu/L | 0.7 ± 0.1 iu/L | >0.05 |
| Total protein | 7.8 ± 0.4 mg% | 7.9 ± 0.2 mg% | >0.05 |
| Albumin | 4.6 ± 0.2 mg% | 4.4 + 0.3 mg% | >0.05 |
| Globulin | 7.5 ± 0.2 mg% | 7.6 + 0.4 mg% | >0.05 |
d) Side effects: There were no significant differences between the mean values of haematocrit, electrolytes, urea, creatinine and the liver function tests at the beginning and at the end of the study (Table 6). None of the patients reported any side effects during the clinical trial. The acceptability of the ointment and soap in terms of appearance, smell, frequency of dosing, and method of application was 100%.
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