Chitosan Loaded Mucoadhesive Microspheres of Gliclazide - Journal

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Methodology Study setting: The study was carried out at dermatology outpatient department of tertiary care teaching hospital situated in the north Karnataka. Study design: This was a prospective, observational, investigational, randomized study. Study criteria: The acne vulgaris patients were enrolled into the study by considering following inclusion and exclusion criteria. Inclusion criteria: • Patients of either sex newly diagnosed with acne vulgaris. • Patients aged from 10 to 38 years. • Patients with acne vulgaris coming on outpatient department basis in the department of dermatology. • Willingness to participate into study. Exclusion criteria: • Patients who are known cases of acne vulgaris. • Special patient population (Pregnant women, Geriatric). • Patients with other co morbidities (include skin disease). Source of data • Case records from dermatology department. • Patient data collection form. • Safety and efficacy (severity index) assessment questionnaire. Study procedure Patients were enrolled by considering inclusion and exclusion criteria and grouped into two groups (group I & II) using simple envelop randomisation technique. Group I patients were treated with Azithromycin 500 mg daily before meals for three consecutive days in 10 days duration of 30 days, the remaining 21 days being drug free. Group II were treated with Doxycycline 100 mg once daily after meals. Topical clindamycin (cream) twice daily was used in all the enrolled patients (Group I & II). Patients were clinically assessed at an interval of 30 days for up to 3 months. At each interval, clinical assessment was done on the severity index of the disease and safety assessment was also done in consultation with dermatologist. The final safety assessment was done and severity index was calculated at the end of the third follow up. Statistical Analysis Mahendra Kumar B.J et al./ Assessment of Safety and Efficacy of Doxycycline and Azithromycin Preparations in Patients with Acne Vulgaris 't' test and 'ANOVA' test were used for calculating significant difference in consulting with biostatistician of the institution. 132 RESULTS During the study period of eight months 8325 patients visited outpatient department of Dermatology, among which 121 patients were diagnosed with acne vulgaris. Out of 121 patients only 53 patients were enrolled into the study by considering inclusion and exclusion criteria. Out of 53, 29 (54.71%) were males and 24 (45.28%) were females. 50 have completed the study, remaining 3 patients did not turn up for the follow up. The incidence in males was slightly higher than in females, with a male female ration of 1: 0.83. Maximum prevalence was seen in the 16 – 20 years age group (54.71%) in both the sexes. Among these, the male prevalence was 58.62% and female prevalence was 50%. Maximum prevalence in males was seen at 17 years and in female at 18years. All other age groups had almost equal sex incidence. The incidence in the 21–25 years age group was 22.64%. The 26–30 years age group had an incidence of 11.32%. The 11–15 and 31–35 years age groups had an incidence of 9.34% and 1.88% respectively. The oldest patient was of 35 years and the youngest was 13 years old. (Table 1). The onsets of acne vulgaris were more in the 16 – 20 years (66.03%) age group. Among these, maximum male patients had their age of onset at 17 years and maximum females had their onset at age 18 years. 12 patients (22.64%) had their age of onset between 11 – 15 years of age. Only 6 patients, with 5 males and 1 female had their age of onset between 21 – 25 years of age. (Table 2). Most of the patients were students 75.47% (40). Other major group was that of factory workers (11.32%) and among these, only one person came in constant contact with oil during his work. (Table 3). Out of 53 patients, 51 (96.22%) were unmarried and only 2 (3.77%) were married. Among 53, 25 patients (47.16%) had acne lesions exclusively on the face. Face was involved in all the 53 patients. 10 patients (18.86%) had lesions on face, chest and back. 8 of them (15.06%) had lesions on the face and Table 1: Age and sex distribution with incidence Age group Male Female No of cases Percentage 11-15 3 2 5 9.43% 16-20 17 12 29 54.71% 21-25 6 6 12 22.64% 26-30 3 3 06 11.32% 31-35 0 1 01 1.88% Number of 29 24 cases P ercentage 55% 45% RJPS, Jul - Sep, 2011/ Vol 1/ Issue 2
Mahendra Kumar B.J et al./ Assessment of Safety and Efficacy of Doxycycline and Azithromycin Preparations in Patients with Acne Vulgaris Table 2 : Age of onset No of cases Age group Males Females Total Percentage (years) 11-15 06 06 12 22.64% 16-20 18 17 35 66.03% 21-25 05 01 06 11.32% Table 3: Occupation Occupation No. of patients Percentage Students 40 75.47% Lecturer 02 03.71% Librarian 01 01.88% Labourer 01 01.88% Housewife 01 01.88% Worker 06 11.32% Watchman 01 01.88% back. 3 patients (5.66%) had lesions on face and chest only. Other 7 patients (13.20%) had lesions on all the four sites (Table 4). All patients were arbitrarily divided into four grades of acne on the basis of severity. Zero patients (0.00%) belonged to grade I acne. Majority of patients 24 (45.28%) had grade II acne. Grade III and IV acne were severe types of acne consisting of cyst on nodules. 24 (45.28%) and 10 (18.86%) belonged to grade III and IV respectively. Among these 24 cases of severe acne, 15 were males and 9 were females (Table 5). About 41 patients gave a history of manual picking among these, 22 were males and 19 were females. Rest of the patients did not give any history of manual picking of their lesions (Table 6). Majority of the patients (35.84%) gave a history of using greasy moisturizing creams. 13.20% of patients gave a history of using talcum powder daily, 11.32% used sandalwood paste, 7.54% used turmeric powder and 1 patient had used pudnia leave (Table 7). Skin type: 42 (79.24%) of the patients described their skin type as oily. 7 (13.20%) of patients called it dry. Rest of them could describe their skin type neither as oily nor as dry. Efficacy assessment of group I and group II: Twenty five patients completed study in group I, who were on treatment with azithromycin and topical clindamycin. The baseline score was 113.36 and the mean severity index declined to 91.08, 62.16 and 9.92 along with the first, second and third follow-ups after the treatment of 30, 60 and 90 days. Decrease percentage was 19.65% in first follow-up, 45.17% and 91.25% in the second and third follow-ups respectively. 133 Table 4: Distribution of Lesions Site No. of patients Percentage Face only 25 47.16% Face and back 08 15.09% Face and chest 03 05.66% Face, chest and back 10 18.86% Face, chest and back arms 07 13.20% Table 5: Severity of Acne Grade No. of patients Percentage I 00 00% II 19 35.84% III 24 45.28% IV 10 18.86% Table 6: History of Manual Picking History No. of patients Percentage Present 41 77.35% Absent 12 22.64% Table 7: Type of Cosmetics and Topical Applications used Types of application No. of patients Percentage Greasy creams 19 35.845 Sandalwood paste 6 11.325 Turmeric 4 7.545 Pudina leaves 1 1.88% Talcum powder 7 13.20% Twenty five patients completed study in group II, who were on treatment with doxycycline and topical clindamycin. The baseline score was 107.32 and the mean severity index declined to 91.44, 66.32 and 28.00 along with the first, second and third follow-ups after the treatment of 30, 60 and 90 days. Decrease percentage was 14.80% in first follow-up, 38.20% and 73.91% in the second and third follow-ups respectively (Table 8). The severity reduction was compared with both drugs and it was tested with t-test for difference between the means; this also showed significant change in the reduction of lesions. The mean severity index of the two drugs was 113.36+19.727 for azithromycin and 107.32+16.790 for doxycycline. After treatment the mean score reduced to 9.92+5.45 and 28+8.377 respectively. There was a significant difference between the severity reduction when comparing the effects of azithromycin and doxycycline (p
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