Photodynamic therapy with methyl aminolaevulinate 80 mg g(-1) for severe facial acne vulgaris: a randomized vehicle-controlled study.

BACKGROUND: Severe acne vulgaris has limited therapeutic options. OBJECTIVES: To evaluate photodynamic therapy (PDT) using topical methyl aminolaevulinate (MAL, 80 mg g(-1) ) as the photosensitizer in severe facial acne. METHODS: A double-blind, randomized, vehicle-controlled multicentre trial in 153 patients (aged 12-35 years) with severe facial acne [Investigator's Global Assessment (IGA) score 4; 25-75 inflammatory lesions with ≤ 3 nodules; 20-100 noninflammatory lesions]. Treatment (four treatments 2 weeks apart) involved incubation with MAL (n = 100) or vehicle cream (n = 53) for 1·5 h under occlusion, then illumination (635-nm red light, total dose 37 J cm(-2) ). IGA assessment and standardized lesion counts were performed before each treatment and 12 weeks after the first treatment. Treatment success was defined as improvement from baseline in IGA by ≥ 2 grades at 12 weeks. Safety assessments were for pain (10-cm visual analogue scale, immediately after illumination), erythema (four-point rating scale) and adverse events. RESULTS: At 12 weeks, PDT using MAL 80 mg g(-1) reduced inflammatory lesions vs. vehicle PDT (mean change -15·6 vs. -7·8, P = 0·006; mean percentage change -37·3% vs. -16·2%, P = 0·003). However, noninflammatory lesions did not decrease significantly (mean change -11·8 vs. -10·7, P = 0·85; mean percentage change -28·6% vs. -24·9%, P = 0·72). Treatment success rates were greater with MAL-PDT 80 mg g(-1) (44% vs. 26%, P = 0·013). Pain was low and manageable by briefly pausing illumination. There was similar pain or erythema with successive treatments. CONCLUSIONS: PDT using topical MAL 80 mg g(-1) and red light may offer promise for severe acne vulgaris.

Treatment of facial erythema in patients with rosacea with topical brimonidine tartrate: correlation of patient satisfaction with standard clinical endpoints of improvement of facial erythema.

BACKGROUND: Once-daily brimonidine tartrate (BT) 0.5% gel was shown to provide significantly greater efficacy vs. vehicle for the treatment of facial erythema in patients with rosacea. OBJECTIVES: To demonstrate that patient satisfaction with overall appearance is correlated with reduction in facial erythema, as measured by clinician and patient assessments. METHODS: Data from two identical phase III, multicentre, randomized, controlled trials of moderate facial erythema of rosacea (study A: n = 260; study B: n = 293) with topical BT 0.5% compared to vehicle gel once-daily for 4 weeks were analysed. Correlations of Patient's Assessment of Appearance (PAA) with Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA) of erythema were evaluated by calculation of gamma statistics. RESULTS: PAA correlated with CEA post-application on Days 1, 15 and 29 for the intent-to-treat population and provided a median gamma value of 0.57 (min = 0.28, max = 0.61). PAA and PSA was also highly correlated post-application on Days 1, 15 and 29; with a median gamma value of 0.87 (min = 0.66, max = 0.89). Subjects who achieved a clinically meaningful improvement in both CEA and PSA scales were more likely to report satisfaction with the overall appearance of their skin (P < 0.001). CONCLUSIONS: Both one- and two-grade improvements in facial erythema assessed by subjects (PSA) and clinicians (CEA) correlate well with PAA, a patient-centered representation of meaningful change.

Once-daily topical brimonidine tartrate gel 0·5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies.

BACKGROUND: Erythema of rosacea is thought to result from abnormal cutaneous vasomotor activity. Brimonidine tartrate (BT) is a highly selective α(2) -adrenergic receptor agonist with vasoconstrictive activity. OBJECTIVE: To determine the optimal concentration and dose regimen of topical BT gel for the treatment of erythema of rosacea and to evaluate its efficacy and safety. METHODS: In study A, 122 subjects were randomized to receive a single application of BT 0·07%, 0·18%, 0·5% or vehicle. In study B (4-week treatment and 4-week follow-up), 269 subjects were randomized to receive BT 0·5% once daily, BT 0·18% once daily, vehicle once daily, BT 0·18% twice daily or vehicle twice daily. Evaluations included Clinician's Erythema Assessment (CEA), Patient's Self-Assessment (PSA), Chroma Meter measurements and adverse events. RESULTS: In study A, a single application of topical BT gel reduced facial erythema in a dose-dependent fashion. A significant difference between BT 0·5% and vehicle in Chroma Meter redness value was observed from 30min to 12h after application. In study B, BT 0·5% once daily had a statistically superior success profile (defined as a two-grade improvement on both CEA and PSA over 12h) compared with vehicle once daily on days 1, 15 and 29 (all P<0·001). No tachyphylaxis, rebound of erythema or aggravation of other disease signs (telangiectasia, inflammatory lesions) was observed. All regimens were safe and well tolerated with similarly low incidence of adverse events. CONCLUSIONS: Once-daily BT gel 0·5% is well tolerated and provides significantly greater efficacy than vehicle gel for the treatment of moderate to severe erythema of rosacea.

A 6-month maintenance therapy with adapalene-benzoyl peroxide gel prevents relapse and continuously improves efficacy among patients with severe acne vulgaris: results of a randomized controlled trial.

BACKGROUND: Acne vulgaris is a chronic and frequently recurring disease. A fixed-dose adapalene-benzoyl peroxide (adapalene-BPO) gel is an efficacious and safe acne treatment. OBJECTIVES: To assess the long-term effect of adapalene-BPO on relapse prevention among patients with severe acne after successful initial treatments. METHODS: This is a multicentre, double-blind, randomized and controlled study. In total, 243 subjects who had severe acne vulgaris and at least 50% global improvement after a previous 12-week treatment were randomized into the present study to receive adapalene-BPO gel or its vehicle once daily for 24 weeks. RESULTS: At week 24, compared with vehicle, adapalene-BPO resulted in significantly higher lesion maintenance success rate (defined as having at least 50% improvement in lesion counts achieved in initial treatment) for all types of lesions (total lesions: 78·9% vs. 45·8%; inflammatory lesions: 78·0% vs. 48·3%; noninflammatory lesions: 78·0% vs. 43·3%; all P < 0·001). Significantly more subjects with adapalene-BPO than with vehicle had the same or better Investigator's Global Assessment score at week 24 than at baseline (70·7% vs. 34·2%; P < 0·001). The time when 25% of subjects relapsed was 175 days with adapalene-BPO and 56 days with vehicle (17 weeks earlier; P < 0·0001). Adapalene-BPO led to further decrease of lesion counts during the study and 45·7% of subjects were 'clear' or 'almost clear' at week 24. It was also safe and well tolerated in the study. CONCLUSIONS: Adapalene-BPO not only prevents the occurrence of relapse among patients with severe acne, but also continues to reduce disease symptoms during 6 months.

Pleural effusions in hospitalized patients receiving long-term hemodialysis.

OBJECTIVE: To determine the incidence, causes, and clinical features of pleural effusions in hospitalized patients receiving long-term hemodialysis. DESIGN: Retrospective. PARTICIPANTS: One hundred patients receiving hemodialysis for at least 3 months with pleural effusion hospitalized at the Medical University of South Carolina hospitals. RESULTS: The incidence of pleural effusions in hospitalized patients receiving long-term hemodialysis was 21%. The mean (+/- SEM) age was 55 +/- 1.4 years and the male to female and black to white ratios were 3:2. Pleural effusions resulted from heart failure in 46% and nonheart failure causes in 54%. Uremic pleurisy (n = 16), parapneumonic effusion (n = 15), and atelectasis (n = 11) accounted for most of the nonheart failure causes of pleural effusions. Three of 15 (20%) parapneumonic effusions were empyemas. The presence of chest pain was not different in patients with parapneumonic effusions than in other patients with nonheart failure effusion (all p = NS) but was more frequent compared to those with heart failure (p = 0.006). Patients with parapneumonic effusions (p = 0.0006) and atelectasis (p = 0.003) were more likely to have unilateral pleural effusions than patients with heart failure. CONCLUSIONS: Pleural effusions are common in hospitalized patients receiving chronic hemodialysis. Although heart failure was the most common cause, other diseases were responsible for most of the effusions. The presence of a unilateral effusion suggests a diagnosis other than heart failure, most commonly parapneumonic effusion or atelectasis and deserves prompt thoracentesis as these effusions often cannot be reliably differentiated clinically. The reduced humoral and cellular immunity, in addition to delay in diagnosis because of an attenuated clinical response, may explain the high rate of empyemas in this study population.

Acute hypoxemic respiratory failure following intrapleural thrombolytic therapy for hemothorax.

Intrapleural instillation of thrombolytic agents has been useful in the treatment of hemothorax when thoracostomy tube drainage is unsuccessful. We present a patient who developed acute hypoxemic respiratory failure following the intrapleural instillation of both streptokinase and urokinase 24 h apart. Hypoxemia most likely resulted from a direct effect of the products of fibrinolysis on the pulmonary circulation.

Familial acanthosis nigricans.

A mother and daughter had benign familial acanthosis nigricans. Familial acanthosis nigricans begins in early childhood and may be accentuated at puberty. The eruption is not associated with underlying illness. Forms of acanthosis nigricans are associated with obesity, endocrinologic abnormalities, drug ingestion, and malignant neoplasms.

Infantile acropustulosis.

Infantile acropustulosis is a syndrome that is characterized by recurrent crops of 1- to 2-mm, intensely pruritic vesicopustules on the distal extremities. The eruption is unresponsive to topical steroids, and pruritus is relieved only by soporific doses of antihistamines.

Annular erythema of infancy.

The lesions of an unusual annular erythema in an infant evolved from erythematous papules, to rings, to interrupted arcs over 36 to 48 hours, and then resolved without a trace. New lesions appeared and evolved with remarkable uniformity for eight months and then disappeared. This seemingly unique eruption is compared with other annular erythemas described in infants.

Persistent subcutaneous abscesses following Pseudomonas sepsis. Treatment by surgical incision and drainage.

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.

Botryomycosis. A bacterial cause of mycetoma.

Botryomycosis is a chronic, granulomatous, bacterial infection in which grains are produced. Clinically, it may not be distinguished from a mycetoma of fungal origin. A case is reported in which the causative organisms were Staphylococcus aureus and Pseudomonas aeruginosa.

Progressive nodular histiocytoma.

Extensive evaluation of the condition of a 9-year-old girl with a previously undescribed proliferative histocytic syndrome showed normal serum and tissue lipid values, which rule out the known lipid storage diseases. Clinically and histologically the case is inconsistent with any of the recognized xanthomatoses or histiocytic abnormalities.

Twenty-nail dystrophy of childhood.

Twenty-nail dystrophy is an idiopathic nail dystrophy that begins insidiously in early childhood. All 20 nails are uniformly affected with excessive longitudinal striations and loss of nail luster. The skin and its ectodermal derivatives are otherwise normal. Twenty-nail dystrophy is believed to be a self-limited abnormality that resolves slowly with age.

Clindamycin phosphate 1% gel in acne vulgaris.

A 12-week study compared Clindagel, a unique water-based gel formulation of clindamycin phosphate 1%, administered once daily, and Cleocin T, a slightly different gel formulation indicated for twice-daily use, in the treatment of acne vulgaris. Clindagel was safe and effective and equivalent to Cleocin T gel, albeit with a better tolerability profile. Clindagel is a viable alternative to Cleocin T gel.

Randomized controlled trial of the tolerability, safety, and efficacy of adapalene gel 0.1% and tretinoin microsphere gel 0.1% for the treatment of acne vulgaris.

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%.