SOLAR (BRACHIORADIAL) PRURITUS—RESPONSE TO CAPSAICIN CREAM

Background. Solar (brachioradial) pruritus is an enigmatic condition affecting the lateral aspects of the arm(s) and is primarily seen in Caucasian people living in the tropics or subtropics. Methods. Over a 5-year period we prospectively evaluated 68 patients with solar pruritus seen in an outpatient dermatology clinic. Clinical, biochemical, and microscopic and ultramicroscopic studies were performed. An open-label trial of capsaicin cream application was initiated in 15 patients. Results. An almost equal number of men and women were seen with an average age of 44 years. Brown-eyed and blue-eyed patients were seen with equal frequency. Most patients (86%) had outdoor occupations or avocations. The pruritus was intense, usually bilateral (72%) and invariably affected the lateral (as opposed to medial) aspects of the arm(s) in the absence of primary lesions. The most commonly affected area was the elbow area superficial to the brachioradialis and extensor carpi longus muscles, but extension of the pruritus to include the forearm and/or upper arm was common. Biopsy specimens (stained with hematoxylin and eosin) were normal or showed mild actinic elastosis in 15 patients tested. Ultramicroscopy showed myelin sheath splitting in all four patients studied. This is a nonspecific finding that may also be found in diabetic or alcoholic neuropathy. Ten of thirteen patients completing the capsaicin-cream study found significant relief (itching much improved or gone) after 3 weeks compared with the untreated control arm. Conclusions. The cause of solar pruritus remains unknown, but circumstantial evidence implicates chronic exposure to solar radiation. Capsaicin may offer relief to these patients, but the patients need to be cautioned about the burning sensation that occurs with capsaicin cream.     

1% sulconazole cream v 2% miconazole cream in the treatment of tinea versicolor. A double-blind, multicenter study

Sulconazole nitrate, a new imidazole derivative, was formulated at 1% concentration in a cream vehicle and compared with 2% miconazole nitrate cream in the treatment of tinea versicolor in a double-blind, multicenter, randomized, parallel clinical trial. At baseline, all of the 192 patients enrolled had a positive potassium hydroxide (KOH) preparation; itching was reported by 48% of the patients. The medications were applied twice daily for three weeks. Of 181 patients analyzed for efficacy at the end of the treatment trial, 93% of sulconazole-treated patients and 87% of miconazole-treated patients had become KOH negative. The complete clearing of tinea versicolor lesions occurred in 89% of sulconazole-treated patients and 82% of miconazole-treated patients. Both drugs were well tolerated with no systemic reactions reported. Drug-related adverse cutaneous reactions, predominantly transient itching, were reported in eight patients receiving sulconazole and in four patients receiving miconazole.     

Seborrhoeic dermatitis of the scalp treated with a tar/zinc pyrithione shampoo

Seventy patients with seborrhoeic dermatitis of the scalp, participated in a double-blind clinical trial using a tar/zinc pyrithione shampoo versus a placebo shampoo. Fifty-seven patients were evaluated after 6 weeks of treatment. Seventeen of twenty-seven using active shampoo and seven of thirty who used the placebo had no itching or scaling at the conclusion of the trial (P9 < O.01). No significant differences between the active and placebo shampoos were found for the parameters of erythema, seborrhoea and excoriations.     

Oral zinc sulfate treatment for viral warts: an open-label study

Viral warts, which are caused by the human papilloma virus, are a common problem in dermatology. Various modalities have been used to treat warts, but none are uniformly effective or directly antiviral. Recent studies show that oral zinc sulfate could be effective in the treatment of viral warts. Thirty-one patients with multiple, non-genital viral warts were recruited in this open-label clinical study. The patients were treated with oral zinc sulfate (10 mg/kg to a maximum dose of 600 mg/day) for 2 months and followed up with assessments for the resolution of their warts and for any evidence of recurrence after treatment. Among the 31 patients, 18 patients showed low serum zinc levels (58%). Of 26 patients who completed the study (84%), 13 (50%) showed complete resolution of their warts after 2 months of treatment. Complete responders remained free of lesions at 6-month follow-up. No serious side-effects were reported apart from nausea (16%), mild gastric pain (3%) and itching sensation (3%). Oral zinc sulfate was found to be a good option in the treatment of viral warts, as it was safe and effective without important side-effects.     

Topical acyclovir in the treatment of initial genital herpes

In a double-blind randomised placebo-controlled trial of topical acyclovir in initial (first episode) genital herpes 18 patients received acyclovir ointment and 22 matching placebo ointment. Acyclovir significantly reduced the duration of viral shedding from external and all genital lesions, the duration of vesicles, the time to crusting, the time to complete healing of external and all genital lesions, new lesion formation, and the duration of pain, itching, and all symptoms combined for all patients. In female patients alone the time to crusting was not significantly different and the duration of pain only approached significance but the effects were otherwise the same as for all patients. No patients reported any adverse effects of treatment. Topical acyclovir is well tolerated and effective in treating initial genital herpes.     

Topical acyclovir in the treatment of initial genital herpes.

In a double-blind randomised placebo-controlled trial of topical acyclovir in initial (first episode) genital herpes 18 patients received acyclovir ointment and 22 matching placebo ointment. Acyclovir significantly reduced the duration of viral shedding from external and all genital lesions, the duration of vesicles, the time to crusting, the time to complete healing of external and all genital lesions, new lesion formation, and the duration of pain, itching, and all symptoms combined for all patients. In female patients alone the time to crusting was not significantly different and the duration of pain only approached significance but the effects were otherwise the same as for all patients. No patients reported any adverse effects of treatment. Topical acyclovir is well tolerated and effective in treating initial genital herpes.     

A randomized trial on the D-homosteroid domoprednate (Ro 12-7024) in the treatment of dermatoses

39 patients with bilateral dermatoses, mainly psoriasis vulgaris and atopic dermatitis, were treated with 0.1% Ro 12-7024 ointment and 0.1% betamethasone valerate ointment according to a double-blind, right-left, randomized design. Treatment lasted up to 4 weeks. 5 patients did not complete the trial. Assessment of efficacy, expressed as degree of healing in percent of treated skin area and according to an overall assessment of efficacy made by both physician and patient only revealed marginal, mostly statistically insignificant differences, with a trend in favor of betamethasone. Patients' preferences for one of the two treatments favored betamethasone valerate in 17 cases and Ro 12-7024 in 5 cases; 13 cases were ties (p less than 0.001). With the exception of one case of bilateral erythema and itching no side effects were reported. The efficacy of the D-homosteroid Ro 12-7024 is evidently of the same order as that of the group III steroid betamethasone valerate, and the tolerance of the two ointments is good and equal.     

Systematic review of topical capsaicin in the treatment of pruritus

Objective To determine the efficacy of topical capsaicin in treating pruritus in any medical condition. Data sources Cochrane library, Medline, Embase, Cinahl and Amed, up to April 2008. No language restrictions. Study selection Randomized, controlled trials comparing topically applied capsaicin with placebo or other standard treatment in patients with pruritus, independently selected by two reviewers. Data extraction Independently extracted by two reviewers. Quality assessed using the Jadad scale. Data synthesis Six randomized controlled trials were identified for inclusion. Three were for hemodialysis‐related pruritus and provided insufficient data for the efficacy of topical capsaicin to be evaluated. A crossover study of capsaicin for treating idiopathic intractable pruritus ani reported a statistically significant difference in responder rates favoring capsaicin over placebo for itching scores but included insufficient data for the validity of this result to be assessed. A study on notalgia paresthetica reported a statistically significant difference in the first phase of a crossover study favoring capsaicin over placebo in a visual analogue scale for itch intensity but failed to report data for a second outcome measure. The final study on brachioradial pruritus used an inappropriate design and reported no significant reduction in itch between capsaicin and placebo. Conclusion At present, there is no convincing evidence for the use of capsaicin to treat pruritus in any medical condition. Further research is needed, and should attempt to address methodological issues identified through this review including unblinding and the suitability of crossover designs.     

Tacrolimus ointment for the treatment of psoriasis on the face and intertriginous areas

The safety and efficacy of 0.1% tacrolimus ointment for the treatment of psoriasis on the face, intertriginous areas, or both were evaluated in an open-label, clinical trial of 21 patients with psoriasis. Patients applied 0.1% tacrolimus ointment twice daily for 8 weeks. Efficacy was assessed through the investigator's evaluation of the individual signs and symptoms of psoriasis, and the physician's global evaluation of change in disease status. Assessments of cutaneous atrophy and other adverse events were made throughout the study to evaluate the safety of tacrolimus ointment. A total of 21 patients were enrolled in the study; 21 patients at least 18 years of age received study medication. Statistically significant improvement in the physician's assessment of the individual signs and symptoms was observed during the study. A total of 81% of patients (17 of 21) experienced complete clearance at day 57 (end of treatment). Only 2 patients reported adverse events, which were limited to itching and the feeling of warmth at the application site. None of the patients had atrophy, telangiectasia, or striae develop during the study. In summary, tacrolimus 0.1% ointment may be a safe and effective treatment option for patients with psoriasis on the face, intertriginous areas, or both.     

A double-blind clinical trial with a lotion containing 5% benzoyl peroxide and 2% miconazole in patients with acne vulgaris

The therapeutic efficacy of a lotion containing 5% benzoyl peroxide and 2% miconazole was compared with 5% benzoyl peroxide alone, in a double-blind, randomized, parallel study. Thirty patients with comedonal or inflammatory acne vulgaris were enrolled. The medications were applied once daily during the first week, and then twice daily for the rest of the trial (45 days). In patients with comedonal acne there was no difference in the effect of the two therapies. In patients with inflammatory acne the percentage reduction of the number of lesions on Day 30 was significantly higher in the benzoyl peroxide plus miconazole group (66%) compared to benzoyl peroxide alone (37%). At Day 45 there was a trend favouring the combined therapy but the difference was not significant. There were no significant differences in the adverse reactions reported by the two groups of patients (erythema, itching or moderate exfoliation).     

Efficacy and tolerability of natural synergised pyrethrins in a new thermo labile foam formulation in topical treatment of scabies: a prospective,randomised, investigator-blinded,comparative trial vs. permethrin cream

We compared in a prospective, randomised, investigator-blinded trial, the efficacy and tolerability of a new synergised-pyrethrins thermo-labile foam (F) formulation with permethrin 5 % cream (P) in 40 patients with scabies. Clinical evolution of scabetic lesions (Clinical grading = CG) and itching intensity (IS) were assessed, using a 5-point semi-quantitative score, at baseline, at week 2 and 4. F and P were equally effective in the clinical resolution of scabetic lesions. As compared to baseline, P reduced CG and IS from 3.4 0.7 and 3.1 0.4 to 0.2 0.6 and 1.4 1, at week 2, and to 0.0 0.0 and 0.1 0.3 at week 4, respectively (P < 0.001). F reduced CG and IS from 3.3 0.5 and 3.2 0.4 to 0.05 0.2 and 0.4 0.6 (week 2) and to 0.0 0.0 and 0.0 0.0 (week 4), respectively (P < 0.0001). As compared to P group, the IS in F group, at week 2, was significantly lower (0.4 0.6 vs. 1.4 1.1) (P < 0.0013). This foam formulation was at least as effective as permethrin 5 % cream in the treatment of scabies. In comparison with permethrin the foam induced a more rapid and complete resolution of itching.     

Oxatomide in the treatment of pruritus senilis. A double-blind placebo-controlled trial

The antiallergic drug oxatomide was evaluated in a double-blind placebo-controlled study in 35 patients with pruritus senilis. The trial was run in the wintertime, and the patients were orally given either 30 mg oxatomide b.i.d. (n = 19) or a placebo (n = 16) for 2 months. Complete suppression or marked improvement of the complaints was experienced by 79% of the patients given oxatomide and by 31% of the control patients. Oxatomide was superior to the placebo in reducing both the duration and the severity of itching. The need of additional topical medication was higher in the placebo group. Somnolence and cramps were each reported by 1 oxatomide-treated patient.     

Effects of topically applied capsaicin on moderate and severe psoriasis vulgaris

Alterations in the cutaneous vascular system are prominent in psoriasis and may play an important role in the pathogenesis of this disorder. We evaluated the effects of topically applied capsaicin (trans-8-methyl-N-vanillyl-6-nonenamide), a known inhibitor of cutaneous vasodilatation, on moderate and severe psoriasis. Under a double-blind paradigm, forty-four patients with symmetrically distributed psoriatic lesions applied topical capsaicin to one side of their body and identical-appearing vehicle to the other side for 6 weeks. After 3 and 6 weeks of treatment, we performed ratings on changes in scaling and erythema, as well as overall improvement of the psoriasis. Over the course of the study, significantly greater overall improvement was observed on sides treated with capsaicin compared to sides treated with vehicle. Similarly, significantly greater reductions in scaling and erythema accompanied capsaicin application. Burning, stinging, itching, and redness of the skin were noted by nearly half of the patients on initial applications of study medication but diminished or vanished upon continued application. These results suggest that topical application of capsaicin may be a useful new approach in the treatment of psoriasis.     

Transcutaneous nerve stimulation and itching.

The response to transcutaneous nerve stimulation (TNS)--a method used for treatment of chronic pain--was studied in 41 patients with itching of diverse etiology. At a first trial, 63% of the patients found that TNS ameliorated their itching, 20% reported complete relief. As a rule the effect lasted for many hours, although TNS was given only for 5-30 min. In 15 of the patients, having suffered from extensive pruritus for more than one year, TNS was given several times a day for 5-47 days. During this time the effect declined. Twelve patients were relieved initially, either partially or completely, but ultimately only 6 had a partial relief and in none had the itching disappeared completely. Only one patient wanted to continue the TNS therapy. The decreasing efficacy is discussed; probably there was an initial placebo effect which declined during the course of treatment. The results indicate that TNS is of limited value for treating chronic itching.     

Tacrolimus ointment in the treatment of eyelid dermatitis

The safety and efficacy of tacrolimus ointment 0.1% (Protopic) in the treatment of atopic dermatitis of the eyelids were assessed in an open-label clinical trial of 21 patients with moderate to severe eyelid dermatitis. Of those 21 patients, 20 received study drug and were followed. Patients applied tacrolimus ointment 0.1% twice daily for 8 weeks and were followed for 2 additional weeks after the last day of treatment. Complete eye examinations were conducted throughout the study. Efficacy was assessed through the investigator's evaluation of the patients' individual signs and symptoms of eyelid dermatitis and the physician global assessment (PGA) of eyelid clinical response. Improvement in the investigator's evaluation of the signs and symptoms of eyelid dermatitis was observed during the study. A total of 80% of patients (16/20) experienced marked improvement or better in PGA at 8 weeks. Adverse events were limited to local burning and itching after the first few applications of study medication. Of the 20 patients, 12 reported burning (60%), and 5 reported itching (25%). There was no statistically significant increase in intraocular pressure (IOP) during the study compared with baseline. In addition, none of the patients developed cataracts or glaucoma during the study. In summary, tacrolimus ointment 0.1% may be a safe and effective treatment option for patients with moderate to severe eyelid dermatitis.     

Amcinonide vs. betamethasone dipropionate ointments in the treatment of psoriasis

A randomized, double-blind study compared the efficacy and safety of amcinonide and betamethasone dipropionate ointments, applied twice daily for two weeks, in the treatment of patients with moderate to severe psoriasis. Thirty-four patients were enrolled; thirty patients had had psoriasis for more than one year, and in the majority of patients, it was stable or slowly exacerbating. Significant improvement from baseline was observed with both ointments at weeks 1 and 2. The two drugs showed comparable cosmetic acceptability. Adverse cutaneous symptoms experienced were burning (both groups), itching (amcinonide), and stinging (beta-methasone); no serious adverse effects were reported.     

Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis

OBJECTIVE: To assess the efficacy and safety of a 24-week course of efalizumab. DESIGN: Phase 3, randomized, double-blind, parallel-group, placebo-controlled 12-week study followed by a 12-week open-label study. SETTING: Outpatient dermatology clinics.Patients A total of 556 patients with moderate to severe chronic plaque psoriasis who were seeing an outpatient dermatologist were included in the study.Intervention For weeks 1 to 12, the 556 patients were randomized to receive 1 mg/kg of efalizumab weekly or placebo subcutaneously. For weeks 13 to 24, 516 of these patients received 1 mg/kg of efalizumab weekly. MAIN OUTCOME MEASURES: Proportion of patients with a 75% or greater improvement in Psoriasis Area and Severity Index (PASI-75), a 50% or greater improvement in PASI (PASI-50), static Physician's Global Assessment (sPGA) rating of minimal or clear, and improvements in Dermatology Life Quality Index (DLQI), itching scale, and Psoriasis Symptom Assessment (PSA) frequency and severity scores at weeks 12 and 24. Safety was evaluated by reviewing adverse events, laboratory parameters, vital signs, and anti-efalizumab antibodies. RESULTS: At week 12, 26.6% of efalizumab-treated patients achieved PASI-75 and 58.5% achieved PASI-50. After 24 weeks of continuous efalizumab therapy, PASI responses increased: 43.8% of patients achieved PASI-75 and 66.6% achieved PASI-50. The percentage of patients who achieved an sPGA rating of minimal or clear increased from 25.7% to 35.9%. The mean percentage of improvement in all patient-reported outcomes (DLQI, itching scale, and PSA frequency and severity scores) at week 12 was maintained at week 24 (DLQI, 49.2%; itching scale, 42.2%; PSA frequency, 47.6%; PSA severity, 47.3%). There was a decline in overall reported adverse events from weeks 1 to 12 (80.4%) to weeks 13 to 24 (63.2%) without evidence of cumulative toxic effects.Conclusion Extending efalizumab treatment from 12 to 24 weeks leads to improved efficacy and maintenance of quality of life with no evidence of cumulative toxic effects noted in patients with moderate to severe chronic plaque psoriasis.     

Long-term follow up of patients with toenail onychomycosis after treatment with terbinafine

The long-term outcome of 111 patients treated with oral terbinafine for toenail onychomycosis with a novel treatment protocol was assessed a median of 138 weeks alter entry into the trial. All but three patients had either one or two 12 week courses of terbinafine 250 mg daily. 01 the 77 evaluable patients, 72.7% were still classified as responders (i.e. negative mycological culture and at least 3 mm olnew unaffected nail growth) on reassessment. The present study shows that a favourable long-term outcome can be achieved in patients who have been treated with at least one 12 week course of terbinafine.     

A New Treatment for Cutaneous Candidiasis: Sulconazole Nitrate Cream 1%

Sulconazole nitrate cream 1%, a new topical imidazole compound with a broad antifungal activity, was compared to its vehicle and to miconazole nitrate cream 2% in two double-blind parallel studies involving 96 patients with cutaneous candidiasis. Once daily application of sulconazole was as effective as twice daily application of miconazole and produced KOH and culture cures in 100% and 88% of patients, respectively. No systemic adverse reactions were reported. One vehicle-treated patient developed itching; six sulconazole- and three miconazole-treated patients developed erythema and/or pruritus, which was mild and transient. Sulconazole used bid was significantly superior to its vehicle and produced KOH and culture cures in 100% of patients.     

The effect of a new non-sedative H1-receptor antagonist (LN2974) on the itching and scratching of patients with atopic eczema

Ten adult male patients with long-standing atopic eczema took part in a double-blind randomized cross-over trial of compound LN2974. This is a new potent selective H₁-receptor antagonist, unrelated to other antihistamines and devoid of H₂-reccptor antagonist activity. It has little or no sedative action. No significant suppression of scratching, as measured by limb movement meters, or of itching, recorded on visual analogue scales, could be demonstrated.