SummaryThe purpose of this double-blind, placebo-controlled study was to evaluate the clinical efficacy and tolerability of topical Aloe veru extract 0.5% in a hydrophilic cream to cure patients with psoriasis vulgaris. Sixty patients (36Mf24F) aged 18-50 years (mean 25.6) with slight to moderate chronic plaque-type psoriasis and PASI (Psoriasis Area and Severity Index) scores between 4.8 and 16.7 (mean 9.3) were enrolled and randomized to two parallel groups. The mean duration of the disease prior to enrolment was 8.5 years (range 1-21). Patients were provided with a precoded IOO g tube, placebo or active (with 0.5% Aloe veru extract), and they self-administered trial medication topically (without occlusion) at home 3 times daily for 5 consecutive days per week (maximum 4 weeks active treatment). Patients were examined on a weekly basis and those showing a progressive reduction of lesions, desquamation followed by decreased erythema, infiltration and lowered PASI score were considered healed. The study was scheduled for 16 weeks with 12 months of follow-up on a monthly basis. The treatment was well tolerated by all the patients, with no adverse drug-related symptoms and no dropouts. By the end of the study, the Aloe veru extract cream had cured 25/30 patients (83.3%) compared to the placebo cure rate of 2/30 (6.6%) (P
SummaryThe prevalence of onychomycosis, a superficial fungal infection that destroys the entire nail unit, is rising, with no satisfactory cure. The objective of this randomized, double-blind, placebo-controlled study was to examine the clinical efficacy and tolerability of 2% butenafine hydrochloride and 5% Melaleuca alternifolia oil incorporated in a cream to manage toenail onychomycosis in a cohort. Sixty outpatients (39 M, 21 F) aged 18-80 years (mean 29.6) with 6-36 months duration of disease were randomized to two groups (40 and 20), active and placebo. After 16 weeks, 80% of patients using medicated cream were cured, as opposed to none in the placebo group. Four patients in the active treatment group experienced subjective mild inflammation without discontinuing treatment. During follow-up, no relapse occurred in cured patients and no improvement was seen in medication-resistant and placebo participants.
The objective of this double-blind, placebo-controlled study was to evaluate in males the clinical efficacy in treating molluscum contagiosum and tolerance of an analog of imiquimod (1%) in cream. One hundred patients between 9 and 27 years of age (mean 16.3), with 733 lesions (mean 7.3), whose size ranged from 2 to 5 mm diameter (mean spot size 3.4 mm) and a biopsy-confirmed diagnosis of molluscum contagiosum were randomized into two parallel groups. In a double-blind manner, precoded 40-g tubes were dispensed. Patients self-administered the trial medication to their lesions at home three times daily for five consecutive days per week. The study was scheduled with 4 weeks of active treatment (maximum 60 topical applications) and 12 months (on a monthly basis) of follow-up. Patients were examined on a weekly basis. Thirteen patients had atopic dermatitis. A clinically and histopathologically confirmed total elimination of lesions was considered as cured. After four weeks of treatment, 49 patients and 372 lesions were cured. Breaking the code revealed that imiquimod cream had cured 82% of the patients and 86.3% of the lesions. Placebo cleared 16% of the patients and 63 of the lesions (p < 0.0001). During the treatment, 88% of the patients experienced no allergic, localized, or drug-related adverse symptoms. Twelve patients, predominantly in the imiquimod cream group reported non-objective, drug-induced, mild reactions with no dropouts. The study was followed-up for 12 months. Among 49 cured patients, 3 had relapses after 10 months. In conclusion, the study demonstrated that 1% imiquimod analog in cream with mild subjective side effects is significantly more efficacious than the placebo in curing molluscum contagiosum in males.
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