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Five hundred and twenty-eight patients with a clinical diagnosis of bacterial conjunctivitis were enrolled in four randomized, double-blind, parallel studies. Patients were treated with trimethoprim-polymyxin B sulphate (TP) or chloramphenicol ophthalmic ointments, four times a day for seven days in three studies, and three times a day for five days in one. Data suitable for evaluation of efficacy and safety were obtained from 448 patients. The results of each study were analysed separately and indicated that both treatments were effective and well tolerated and that there were no statistically significant differences between them. However, in three studies, efficacy trends generally favoured TP ophthalmic ointment and in one study efficacy trends favoured chloramphenicol ophthalmic ointment. A wide range of pathogenic or potentially pathogenic organisms was isolated, with Haemophilus influenzae being the most prevalent.
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The antitumor effect of bleomycin (BLM) ointment in combination with lysozyme (LY) ointment was investigated. Nine-week-old male and female WHT/Ht mice were implanted with a graft of WHT squamous cell carcinoma into the subcutis of back, and the skin covering the developed solid tumor was resected 7 days after implantation. Thereafter, the mice were administered twice daily for 7 days with each of the following: 220 mg of 0.25% BLM ointment, 2.5% LY ointment, and a 1:1 mixture of 0.5% BLM ointment plus 5% LY ointment. BLM ointment and the combination of BLM ointment and LY ointment were effective with an inhibition rate of 79.3 and 89.7%, respectively. The inhibition rates of these groups showed a statistically significant increase over that of control group. Further, the rate of the combination group displayed a statistically significant increase over that of the BLM ointment group. Formation of crusta on the solid tumor was markedly inhibited in the groups applied LY ointment and the combination of LY ointment and BLM ointment. LY was ineffective against cultured cells of WHT squamous cell carcinoma and did not potentiate the antitumor activity of BLM in combination. These results suggest that potentiation of the antitumor effect of BLM ointment in combination with LY ointment is due to inhibition of crusta formation by LY resulting in an increased permeation of BLM into tumor tissue.
BACKGROUND: Weekend therapy with superpotent topical corticosteroids has been used for the long-term treatment of psoriasis. Recently, calcipotriene ointment has been added to this regimen for use on weekdays, but there are no long-term studies of that combination. OBJECTIVE: The purpose of this study was to determine whether the addition of weekday calcipotriene to a pulse therapy regimen of weekend superpotent corticosteroids results in a longer duration of remission of plaque psoriasis. SUBJECTS: This was a double-blind, placebo-controlled, parallel-group study. Forty-four patients with mild to moderate psoriasis were treated with calcipotriene ointment in the morning and halobetasol ointment in the evening for 2 weeks. Thereafter, 40 patients who were at least moderately (50% or greater) improved were randomized to 2 treatment groups. After 2 weeks of treatment with calcipotriene ointment in the morning and halobetasol ointment in the evening, 20 patients were randomized to receive halobetasol ointment twice daily on weekends and calcipotriene ointment twice daily on weekdays, and 20 patients were randomized to receive halobetasol ointment twice daily on weekends and placebo ointment twice daily on weekdays. RESULTS: Seventy-six percent of patients applying halobetasol ointments on weekends and calcipotriene ointment on weekdays were able to maintain remission for 6 months compared with 40% of patients applying halobetasol ointment on weekends only with the vehicle on weekdays. CONCLUSION: The addition of calcipotriene ointment applied on weekdays to a weekend pulse therapy regimen of superpotent corticosteroids can increase the duration of remission of psoriasis.
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This study compared the clinical efficacy and safety of the combination agent mometasone furoate 0.1%-salicylic acid 5% ointment with those of the single agent fluocinonide 0.05% ointment, each applied twice daily for 21 days, in the treatment of patients with moderate to severe plaque psoriasis. Forty adult patients were included in this single-center, randomized, double-masked, intraindividual, bilateral-paired comparative trial. Two similar, bilaterally symmetrical target lesions on the trunk, arms, or legs of each patient were selected for treatment and evaluation. One lesion was treated with mometasone furoate 0.1%-salicylic acid 5% ointment, and the other was treated with fluocinonide 0.05% ointment, both twice daily for 21 days. Treatment was randomly assigned to the right or left side of the body. Signs of psoriasis (ie, erythema, induration, and scaling) and overall clinical response were evaluated and scored on days 4, 8, 15, and 22 and compared against baseline. Patients were asked to evaluate the treatments for efficacy and acceptability at each visit. The primary efficacy parameter was the mean percentage of improvement in total sign scores for the target lesions. Safety was evaluated based on clinical observation and patients' reports. Beginning with day 15, statistically significant differences favoring mometasone furoate 0.1%-salicylic acid 5% ointment over fluocinonide 0.05% ointment were seen in individual and total sign scores, as well as in overall global clinical response. On day 15, 20 patients expressed a preference for one treatment over the other, and 20 patients made no distinction between the two. Of those who expressed a preference, significantly more patients believed mometasone furoate 0.1%-salicylic acid 5% ointment to be better than fluocinonide 0.05% ointment. On day 22, of 25 patients who expressed a preference, significantly more patients thought mometasone furoate 0.1%-salicylic acid 5% ointment was better than fluocinonide 0.05% ointment. No adverse events were recorded for either treatment group. The combination mometasone furoate 0.1%-salicylic acid 5% ointment was significantly more efficacious than and equally as safe as fluocinonide 0.05% ointment in the management of patients with plaque psoriasis and was preferred by a greater number of patients.
A desired ointment bases for better treatment of bedsores was developed to improve the release rate of minocycline hydrochloride (MH) and the water absorption capacity using various types of hydrophobic to hydrophilic ointment base. The influence of purified lanolin (PL) on the release behavior of MH from hydrophilic ointment (HO) base was primarily focused on. It was found that the release rate of drug increased with increase in the hydrophilicity of the base. A linear correlation between the apparent release rate constant of drug from the HO and PL mixed ointment base at various combination ratios and the elution of ointment base was noted. The HO ointment base containing 30% PL had the highest apparent release rate constant of MH. The mixed ointment base with the lowest viscosity showed the highest absorption of water and elution of ointment base. In conclusion, it was found that HO (70%) and PL (30%) mixed ointment base was a promising candidate for better treatment of bedsores.
Sodium fusidate ointment and mupirocin ointment were compared in 354 patients with superficial skin sepsis. The ointments were applied 3-times daily, or once daily when covered by a dressing, and the response assessed after 6 to 8 days. Both preparations proved effective clinically with 86% of patients responding. There was no difference between the two preparations in cases of primary infection (85% to both ointments), including a sub-group with impetigo (sodium fusidate 88% and mupirocin 84%), or secondary infection (sodium fusidate 81% and mupirocin 89%). Sodium fusidate ointment (98%) was significantly better (p less than 0.05) than mupirocin (82%) in patients with other superficial infections. Both ointments were equally effective in cases where Gram-positive, Gram-negative or mixed Gram-positive/Gram-negative bacteria were isolated. Adverse effects were reported in 1.0% of patients using sodium fusidate ointment and in 7.4% of patients using mupirocin ointment. The majority of complaints concerned the greasiness of mupirocin ointment.
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