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1.
J Am Acad Dermatol ; 45(2): 187-95, 2001 Aug.
Article in English | MEDLINE | ID: mdl-11464179

ABSTRACT

BACKGROUND: Isotretinoin is very frequently the drug of choice for the management of severe recalcitrant nodular acne. Recently, a new micronized and more bioavailable formulation of isotretinoin has been developed that permits once-daily administration in lower doses than usually used with standard isotretinoin (Accutane), regardless of whether it is taken with or without food. OBJECTIVE: Our purpose was to determine whether micronized isotretinoin and standard isotretinoin are clinically equivalent. METHODS: In this multicenter, double-blind, double-dummy study, 600 patients with severe recalcitrant nodular acne were treated with either 0.4 mg/kg of micronized isotretinoin once daily without food (n = 300) or 1.0 mg/kg per day of standard isotretinoin in two divided doses with food (n = 300). Lesion counts were monitored over 20 weeks. RESULTS: Both treatment groups in this well-controlled clinical trial experienced an equivalent reduction in the number of total nodules (facial plus truncal). In addition, an equivalent proportion of patients achieved 90% clearance of the total number of nodules. Both formulations had similar results for other efficacy variables. CONCLUSION: Once-daily use of the micronized and more bioavailable formulation of isotretinoin under fasted conditions is clinically equivalent to the standard twice-daily formulation under fed conditions in the treatment of severe recalcitrant nodular acne.


Subject(s)
Acne Vulgaris/drug therapy , Isotretinoin/administration & dosage , Acne Vulgaris/pathology , Adolescent , Adult , Biological Availability , Child , Dosage Forms , Double-Blind Method , Drug Administration Schedule , Female , Humans , Isotretinoin/pharmacokinetics , Male , Middle Aged , Tablets
2.
J Am Acad Dermatol ; 45(2): 196-207, 2001 Aug.
Article in English | MEDLINE | ID: mdl-11464180

ABSTRACT

BACKGROUND: Isotretinoin is a very effective drug for treating severe recalcitrant nodular acne. A new micronized formulation of isotretinoin has been shown to be clinically equivalent to standard isotretinoin with improved bioavailability and minimal food effect. The safety profile of the micronized formulation has not been described previously. OBJECTIVE: The objective of this article is to report the incidence and intensity of adverse events found in a comparative, double-blind efficacy study that showed clinical equivalence of the new micronized formulation of isotretinoin and the standard isotretinoin formulation (Accutane). METHODS: Six hundred patients with severe recalcitrant nodular acne were treated with micronized isotretinoin (n = 300) under fasted conditions or standard isotretinoin (n = 300) under fed conditions. One cohort received single daily doses of 0.4 mg/kg of micronized isotretinoin without food and the other cohort received 1.0 mg/kg per day of standard isotretinoin in two divided doses with food. Adverse events were monitored during 20 weeks of drug therapy. RESULTS: The proportion of adverse events in most body systems was generally lower in patients receiving micronized isotretinoin than in those receiving standard isotretinoin. CONCLUSION: Micronized isotretinoin appears to have a safety profile similar to that of standard isotretinoin and to carry a lower risk of mucocutaneous events and hypertriglyceridemia.


Subject(s)
Acne Vulgaris/drug therapy , Isotretinoin/adverse effects , Acne Vulgaris/pathology , Affect/drug effects , Biological Availability , Depression/chemically induced , Dosage Forms , Double-Blind Method , Drug Administration Schedule , Headache/chemically induced , Humans , Isotretinoin/administration & dosage , Isotretinoin/pharmacokinetics , Lipids/blood , Liver Function Tests , Mucous Membrane/drug effects , Skin/drug effects , Tablets , Xerophthalmia/chemically induced
3.
J Cutan Med Surg ; 5(1): 37-42, 2001.
Article in English | MEDLINE | ID: mdl-11281433

ABSTRACT

BACKGROUND: Topical clindamycin and benzoyl peroxide have each demonstrated clinical efficacy in the treatment of acne vulgaris. When used in tandem, they promise greater efficacy than either individual agent through their antibacterial and anti-inflammatory effects. OBJECTIVE: To determine the efficacy and safety of combination benzoyl peroxide/ clindamycin compared with benzoyl peroxide or benzoyl peroxide/erythromycin in the treatment of acne. METHODS: In this randomized, 10-week, multicenter, single-blind trial, 492 patients with moderate to moderately severe acne were treated twice daily with 5% benzoyl peroxide/1% clindamycin, 5% benzoyl peroxide, or 5% benzoyl peroxide/3% erythromycin and assessed every 2 weeks. RESULTS: Compared with benzoyl peroxide, benzoyl peroxide/clindamycin demonstrated significantly greater reductions in inflammatory lesions (p = 0.04) and significantly greater overall improvement as assessed by physicians (p < or = 0.04) and patients (p < 0.001). Benzoyl peroxide/clindamycin demonstrated a nonsignificant trend for greater efficacy compared to benzoyl peroxide/erythromycin. Dry skin was the most frequent (< or = 7.3%) adverse event with all three therapies. CONCLUSION: Benzoyl peroxide/clindamycin demonstrated improved efficacy and similar tolerability; to benzoyl peroxide used alone and was similar to benzoyl peroxide/ erythromycin, making this combination product an effective alternative antimicrobial therapy for acne.


Subject(s)
Acne Vulgaris/drug therapy , Anti-Bacterial Agents/administration & dosage , Benzoyl Peroxide/administration & dosage , Clindamycin/administration & dosage , Erythromycin/administration & dosage , Administration, Topical , Adolescent , Drug Combinations , Female , Gels , Humans , Male , Single-Blind Method
4.
Cutis ; 68(4 Suppl): 10-9, 2001 Oct.
Article in English | MEDLINE | ID: mdl-11845943

ABSTRACT

A prior meta-analysis of 5 randomized controlled trials indicates that adapalene gel 0.1% is as effective as tretinoin gel 0.025% against acne and has greater tolerability. To determine the tolerability and efficacy of adapalene gel 0.1% versus tretinoin microsphere gel 0.1% in 168 patients with acne vulgaris, we conducted a 12-week, multicenter, randomized, controlled, investigator-masked, parallel-group design study. Efficacy variables included noninflammatory, inflammatory, and total lesion counts; global grade; and global assessment of improvement in acne severity. Skin tolerability variables included erythema, desquamation (scaling), dryness, pruritus, and stinging/burning. Our results showed that the efficacy of adapalene gel 0.1% was comparable to that of tretinoin microsphere gel, and both treatments had similar onset of action. Cutaneous tolerability was noted in both groups, with scores significantly better with adapalene gel 0.1% than with tretinoin microsphere gel 0.1%, and significantly fewer treatment-related adverse events were reported with adapalene gel 0.1%.


Subject(s)
Acne Vulgaris/drug therapy , Dermatologic Agents/therapeutic use , Naphthalenes/therapeutic use , Adapalene , Administration, Topical , Adolescent , Adult , Child , Dermatologic Agents/adverse effects , Female , Humans , Keratolytic Agents/adverse effects , Keratolytic Agents/therapeutic use , Male , Naphthalenes/adverse effects , Sensitivity and Specificity , Treatment Outcome , Tretinoin/adverse effects , Tretinoin/therapeutic use
5.
J Am Acad Dermatol ; 38(6 Pt 2): S95-102, 1998 Jun.
Article in English | MEDLINE | ID: mdl-9631991

ABSTRACT

BACKGROUND: Fluconazole is a bis-triazole antifungal agent approved for the treatment of oropharyngeal, esophageal, and vaginal candidiasis, serious systemic candidal infections, and cryptococcal meningitis. OBJECTIVE: The purpose of this study was to evaluate three different durations of once-weekly fluconazole for the treatment of onychomycosis of the toenail caused by dermatophytes. METHODS: In a multicenter, randomized, double-blind, parallel, placebo-controlled trial, 384 patients with distal subungual onychomycosis of the toenail received fluconazole, 450 mg once weekly, or placebo for 4, 6, or 9 months. For inclusion, patients were required to have mycologically confirmed distal subungual onychomycosis of the toenail with a large toenail at least 25% clinically affected but having at least 2 mm of healthy nail between the nail fold and the proximal onychomycotic border. Efficacy was assessed by clinical and mycologic (microscopic and microbiologic) measures at screening, at every treatment visit starting at month 3, and at months 2, 4, and 6 after therapy. Observed or volunteered adverse events were recorded and classified at all visits. RESULTS: At the end of treatment, very significantly superior clinical and mycologic results were achieved in all fluconazole groups compared with placebo (p=0.0001). This superiority was largely maintained over 6 months of follow-up. The clinical and mycologic responses of the 9-month treatment duration were significantly superior to the 4- and 6-month durations. Similar percentages of patients in the fluconazole and placebo groups reported adverse experiences for all three durations of the study. CONCLUSION: Results of this study support the efficacy and safety of fluconazole in the treatment of distal subungual onychomycosis of the toenail.


Subject(s)
Antifungal Agents/administration & dosage , Antifungal Agents/adverse effects , Fluconazole/administration & dosage , Fluconazole/adverse effects , Onychomycosis/drug therapy , Adolescent , Adult , Aged , Arthrodermataceae/isolation & purification , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Female , Foot Dermatoses/drug therapy , Humans , Male , Middle Aged , Treatment Outcome
6.
J Am Acad Dermatol ; 38(4): S17-23, 1998 Apr.
Article in English | MEDLINE | ID: mdl-9555822

ABSTRACT

BACKGROUND: The addition of polyolprepolymer-2 in tretinoin formulations may reduce tretinoin-induced cutaneous irritation. OBJECTIVE: This study compared the efficacy and safety of a new 0.025% tretinoin gel containing polyolprepolymer-2, its vehicle, and a commercially-available 0.025% tretinoin gel in patients with mild to moderate acne vulgaris. METHODS: In this 12-week multicenter, double-blind, parallel group study, efficacy was evaluated by objective lesion counts and the investigators' global evaluations. Subjective assessment of cutaneous irritation by the investigators and patients evaluated safety. RESULTS: The efficacy of the two active treatments in this 215 patient study was comparable, and both treatments were statistically significantly more effective than vehicle. When compared with the commercially-available tretinoin gel, the formulation containing polyolprepolymer-2 demonstrated statistically significantly less peeling at days 28, 56, and 84, statistically significantly less dryness by day 84, and statistically significantly less itching at day 14. Irritation scores for the formulation containing polyolprepolymer-2 were numerically lower but not statistically different from those of the commercially-available gel for erythema and burning. The number of cutaneous and noncutaneous adverse events were similar for both active medications. CONCLUSION: The two 0.025% gels studied demonstrated comparable efficacy. However, the gel formulation containing polyolprepolymer-2 caused significantly less peeling and drying than the commercially-available formulation by day 84 of the study.


Subject(s)
Acne Vulgaris/drug therapy , Keratolytic Agents/administration & dosage , Tretinoin/administration & dosage , Administration, Topical , Adult , Double-Blind Method , Female , Gels , Humans , Keratolytic Agents/adverse effects , Keratolytic Agents/chemistry , Male , Ointments , Polypropylenes/administration & dosage , Polyurethanes/administration & dosage , Tretinoin/adverse effects , Tretinoin/chemistry
7.
J Am Acad Dermatol ; 38(4): S24-30, 1998 Apr.
Article in English | MEDLINE | ID: mdl-9555823

ABSTRACT

BACKGROUND: Preclinical study and human patch tests indicate polyolprepolymer-2 may reduce cutaneous tretinoin-induced irritation. OBJECTIVE: This study compared the clinical efficacy and safety of a 0.025% tretinoin cream containing polyolprepolymer-2 and its vehicle to a commercially-available 0.025% tretinoin cream. METHODS: In this 12-week multicenter, double-blind, parallel group study in patients with mild to moderate acne, objective lesion counts and the investigators' global evaluations evaluated efficacy. Subjective evaluations of skin irritation were used to study safety. RESULTS: A total of 271 patients were enrolled. The active treatments demonstrated comparable efficacy that was statistically significantly greater than that of the vehicle. Safety evaluations of cutaneous and noncutaneous adverse events also indicated comparable results of the active treatments. CONCLUSION: The commercially-available 0.025% tretinoin cream and the 0.025% tretinoin cream containing polyolprepolymer-2 demonstrated comparable efficacy and safety.


Subject(s)
Acne Vulgaris/drug therapy , Keratolytic Agents/administration & dosage , Tretinoin/administration & dosage , Administration, Topical , Adult , Double-Blind Method , Female , Humans , Keratolytic Agents/adverse effects , Keratolytic Agents/chemistry , Male , Ointments , Polypropylenes/administration & dosage , Polyurethanes/administration & dosage , Tretinoin/adverse effects , Tretinoin/chemistry
8.
J Am Acad Dermatol ; 29(3): 438-42, 1993 Sep.
Article in English | MEDLINE | ID: mdl-7688774

ABSTRACT

BACKGROUND: Substance P, an undecapeptide neurotransmitter, has been implicated in the pathophysiology of psoriasis and pruritus. OBJECTIVE: Safety and efficacy of topical capsaicin, a potent substance P depletor, were evaluated in patients with pruritic psoriasis. METHODS: Patients applied capsaicin 0.025% cream (n = 98) or vehicle (n = 99) four times a day for 6 weeks in this double-blind study. Efficacy was based on a physician's global evaluation and a combined psoriasis severity score including scaling, thickness, erythema, and pruritus. RESULTS: Capsaicin-treated patients demonstrated significantly greater improvement in global evaluation (p = 0.024 after 4 weeks and p = 0.030 after 6 weeks) and in pruritus relief (p = 0.002 and p = 0.060, respectively), as well as a significantly greater reduction in combined psoriasis severity scores (p = 0.030 and p = 0.036, respectively). The most frequently reported side effect in both treatment groups was a transient burning sensation at application sites. CONCLUSION: Topically applied capsaicin effectively treats pruritic psoriasis, a finding that supports a role for substance P in this disorder.


Subject(s)
Capsaicin/administration & dosage , Psoriasis/drug therapy , Administration, Topical , Adolescent , Adult , Aged , Double-Blind Method , Female , Humans , Male , Middle Aged , Pruritus/drug therapy , Pruritus/metabolism , Psoriasis/metabolism , Substance P/metabolism
10.
J Am Acad Dermatol ; 1(3): 244-8, 1979 Sep.
Article in English | MEDLINE | ID: mdl-512074

ABSTRACT

Phosphonoacetic acid (PAA) was evaluated as therapy for primary cutaneous herpes simplex virus (HSV) infections in guinea pigs. Epilated areas of skin were inoculated with HSV type 1 and treated in a blind fashion with topical PAA 2% cream or placebo cream, the initial application varying from 3 to 84 hours after inoculation. PAA applied 3 hours after inoculation aborts clinical infection. Even when applied 84 hours after inoculation (12 hours after the appearance of clinical lesions), PAA reduces the severity of primary HSV infection, and thus may be suitable for the treatment of human HSV infections.


Subject(s)
Herpes Simplex/drug therapy , Organophosphorus Compounds/therapeutic use , Phosphonoacetic Acid/therapeutic use , Skin Diseases, Infectious/drug therapy , Animals , Croton Oil/therapeutic use , Disease Models, Animal , Drug Evaluation, Preclinical , Female , Guinea Pigs , Male , Placebos
11.
Arch Dermatol ; 115(4): 459-60, 1979 Apr.
Article in English | MEDLINE | ID: mdl-434870

ABSTRACT

Despite appropriate and adequate antibiotic therapy, multiple subcutaneous abscesses developed in a child with Pseudomonas aeruginosa spesis and meningitis. The patient's condition remained toxic until the abscesses were incised and drained.


Subject(s)
Abscess/etiology , Drainage , Pseudomonas Infections , Skin Diseases/etiology , Abscess/surgery , Female , Humans , Infant , Skin Diseases/surgery
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