A novel foam formulation of ketoconazole 2% for the treatment of seborrheic dermatitis on multiple body regions

BACKGROUND: A novel topical foam formulation of ketoconazole has been developed for use on the scalp, body, and face. OBJECTIVE: To evaluate the efficacy and safety of twice-daily treatment with ketoconazole 2% foam for seborrheic dermatitis on the scalp, body, and face. METHODS: One thousand one hundred sixty-two subjects, aged 12 years or older, with mild to severe seborrheic dermatitis were randomized to receive ketoconazole foam (n=427), vehicle foam (n=420), ketoconazole cream (n=210), or vehicle cream (n=105) twice daily for 4 weeks. The primary endpoint was the proportion of subjects achieving an Investigator's Static Global Assessment score of 0 or 1 at week 4 (treatment success). RESULTS: A significantly greater percentage of subjects achieved treatment success using ketoconazole foam than vehicle foam (56% and 42%, respectively; P<.0001); ketoconazole foam was shown to be equivalent to ketoconazole cream. Ketoconazole foam was well-tolerated with a low incidence of treatment-related adverse events (14%; 59/427). CONCLUSION: Ketoconazole foam 2% is a safe, effective, and versatile formulation for use on the scalp, body, and face for the treatment of seborrheic dermatitis in patients aged 12 years or older.     

A new ketoconazole topical gel formulation in seborrhoeic dermatitis: an updated review of the mechanism

Seborrhoeic dermatitis (SD) is a chronic, inflammatory skin disorder, affecting areas of the head and body where sebaceous glands are most prominent and active. The disorder commonly affects hair-bearing areas of the head, including the scalp. Involvement on the face is usually limited to the hairline, eyebrows, nasolabial folds and ears, and may occur either with or without scalp involvement. Areas of the trunk where SD may occur include the body folds and the presternal area. The aetiology of SD is unknown, although hormones and the Malassezia spp., formerly known as Pityrosporum (naturally occurring yeasts), are thought to be involved in the development of the condition. SD responds to the use of antifungal medications such as ketoconazole, suggesting that the inflammation could be linked to the Malassezia spp. The mechanisms behind the therapeutic effect of ketoconazole for the management of SD form the basis of this review. The broad spectrum activity of Ketoconazole was reported in the early 1980s. Due to its potent effect against Malassezia spp. the development of ketoconazole for the treatment of various skin infections, in which a link was proposed with Malassezia spp., was initiated. Later on, a number of ancillary properties were described for ketoconazole, comprising antibacterial, anti-inflammatory, sebostatic and antiproliferative effects. The incorporation of ketoconazole in an adapted vehicle further promoted its efficacy. Recently, a new anhydrous gel containing 2% ketoconazole (Xolegel?) was launched, in which all of the above properties were optimised.     

A new ketoconazole topical gel formulation in seborrhoeic dermatitis: an updated review of the mechanism

Seborrhoeic dermatitis (SD) is a chronic, inflammatory skin disorder, affecting areas of the head and body where sebaceous glands are most prominent and active. The disorder commonly affects hair-bearing areas of the head, including the scalp. Involvement on the face is usually limited to the hairline, eyebrows, nasolabial folds and ears, and may occur either with or without scalp involvement. Areas of the trunk where SD may occur include the body folds and the presternal area. The aetiology of SD is unknown, although hormones and the Malassezia spp., formerly known as Pityrosporum (naturally occurring yeasts), are thought to be involved in the development of the condition. SD responds to the use of antifungal medications such as ketoconazole, suggesting that the inflammation could be linked to the Malassezia spp. The mechanisms behind the therapeutic effect of ketoconazole for the management of SD form the basis of this review. The broad spectrum activity of Ketoconazole was reported in the early 1980s. Due to its potent effect against Malassezia spp. the development of ketoconazole for the treatment of various skin infections, in which a link was proposed with Malassezia spp., was initiated. Later on, a number of ancillary properties were described for ketoconazole, comprising antibacterial, anti-inflammatory, sebostatic and antiproliferative effects. The incorporation of ketoconazole in an adapted vehicle further promoted its efficacy. Recently, a new anhydrous gel containing 2% ketoconazole (Xolegel) was launched, in which all of the above properties were optimised.     

地奈德乳膏联合萘替芬酮康乳膏治疗对面部脂溢性皮炎的效果与安全性

目的探究面部脂溢性皮炎患者实施地奈德乳膏与萘替芬酮康乳膏联合治疗的临床效果。方法择取2017年3月～2018年10月期间我院收治的面部脂溢性皮炎患者40例为研究对象,采取完全随机分组方法将患者分为对照组20例及观察组20例。对照组患者行地奈德乳膏治疗,观察组患者基于地奈德乳膏行萘替芬酮康唑乳膏治疗。对两组患者治疗前后症状积分以及两组患者不良反应情况进行记录和比较。结果两组患者治疗前症状积分数据比较,差异无统计学意义(P> 0.05),治疗后两组患者症状积分相比同组治疗前均有明显下降,其中观察组患者下降幅度更多,差异有统计学意义(P <0.05)。两组不良反应发生率差异无统计学意义(P> 0.05)。结论地奈德与萘替芬酮康唑乳膏联合应用对面部脂溢性皮炎疗效确切,安全性高,可用于临床中推广。     

萘替芬酮康唑乳膏联合地奈德乳膏治疗面部脂溢性皮炎疗效观察

目的:观察萘替芬酮康唑乳膏及地奈德乳膏联合疗法治疗面部脂溢性皮炎的临床疗效。方法:30例面部脂溢性皮炎应用萘替芬酮康唑乳膏及地奈德乳膏联合外用治疗,治疗,2,3周及4周结束后观察临床疗效及不良反应,停药后1,2周随诊。结果:4周后痊愈率为86.67%,总有效率为100%。停药后1,2周随诊未见复发。未发现不良反应。结论:此方法治疗面部脂溢性皮炎治愈率高,疗效显著,耐受性好,安全性高,复发率低,是一种较理想的治疗面部脂溢性皮炎的有效方法。     

The safety and efficacy of ciclopirox olamine for the treatment of seborrheic dermatitis

Ciclopirox olamine is a synthetic hydroxypiridone derived, broad spectrum, antifungal agent which has been used effectively to treat seborrheic dermatitis. Seborrheic dermatitis is a chronic dermatosis, more common in men than women, which usually occurs in sites dense with sebaceous glands in the form of mild inflammatory desquamate erythema. Treatment modalities for seborrheic dermatitis include keratolytic agents, corticosteroids and antifungal agents. Due to its antimycotic and anti-inflammatory activities, ciclopirox olamine is established as an effective treatment for this condition.     

维胺酯胶囊治疗脂溢性皮炎安全性及可行性分析

目的：探讨维胺酯胶囊治疗脂溢性皮炎及可行性分析安全性。方法根据数字表法将84例脂溢性皮炎患者随机分为观察组和对照组,各42例,对照组患者给予1％吡美莫司乳膏外涂,2次/d;观察组在对照组基础上口服维胺酯胶囊50 mg/次,2次/d,2周为1个疗程,连续用药2个疗程。观察两组患者疗效和不良反应。结果观察组治疗4周、8周后红斑、鳞屑、皮脂溢、瘙痒等症状积分及总积分显著低于对照组（红斑t＝5．865、5．786,鳞屑t＝6．112、5．886,皮脂溢t＝5．963、5．629,瘙痒t＝6．123、6．072,均P＜0．05）。观察组治疗1周、4周、8周总有效率分别为57．14％、85．71％、95．24％,对照组分别为42．86％、59．52％、80.95％,差异均有统计学意义（χ2＝5．632、6．986、5．252,均P＜0．05）。观察组复发率为2．38％,低于对照组的19．05％;满意率100．00％,高于对照组的76．19％,差异均有统计学意义（χ2＝5．986、6．123,均P＜0．05）。而两组不良反应发生率差异无统计学意义（χ2＝0．589,P＞0．05）。结论维胺酯胶囊能在较短的时间内改善脂溢性皮炎患者临床症状,效果显著,复发率低,安全有效。     

Pimecrolimus 1% cream for the treatment of seborrheic dermatitis: a systematic review of randomized controlled trials

Seborrheic dermatitis is a common, chronic, relapsing inflammatory skin disorder that manifests as erythema, scaling and pruritus in sebum gland-rich areas of the skin. The objective of this article is to evaluate the clinical efficacy of pimecrolimus 1% cream in the treatment of seborrheic dermatitis compared with corticosteroids, antimycotics, placebo or no intervention. Pimecrolimus 1% cream appears to be a well-tolerated and effective treatment for seborrheic dermatitis. It has comparable efficacy, in terms of decreasing severity of erythema, scaling and pruritus, to the standard treatments: topical corticosteroids and antimycotics. However, future studies with more standardized measures of treatment outcome are recommended. More studies may also be conducted to further evaluate pimecrolimus 1% cream as a long-term maintenance therapy for seborrheic dermatitis.     

辣椒碱治疗关节痛的Ⅱ期临床研究

目的：评价辣椒碱软膏治疗关节痛的疗效和安全性，与外用非甾体抗炎药1％双氯芬酸二乙胺乳胶剂进行随机双盲对比验证。方法：134例有明确关节痛的患者，随机分为辣椒碱组68例和双氯芬酸二乙胺组66例，分别应用0．025％辣椒碱软膏和1％双氯芬酸二乙胺乳剂外涂，治疗1周。结果：辣椒碱软膏和双氯芬酸二乙胺乳胶剂均能显著降低关节疼痛，改善压痛和活动痛的程度，总有效率分别为79．10％和76．92％。辣椒碱软膏比双氯芬酸二乙胺乳胶剂起效快。二者的耐受性均比较好。结论：辣椒碱软膏治疗关节痛有效，安全，迅速。     

The safety and efficacy of clindamycin phosphate foam 1% versus clindamycin phosphate topical gel 1% for the treatment of acne vulgaris

Clindamycin phosphate is the most widely used topical antibacterial agent for acne treatment. Treatment of patients with mild to moderate acne vulgaris with a new foam formulation (clindamycin foam, CF) for 12 weeks was at least as effective as clindamycin gel (CG) based on the Investigator's Static Global Assessment (ISGA) score. CF was superior to CG based on the reduction from baseline in total (P = .0014), inflammatory (P = .0478), and noninflammatory (P = .0037) acne lesion counts. Additionally, CF achieved efficacy that was superior to that of vehicle foam based on ISGA score (P = .0025) and all 3 lesion counts (all P < .05). Adverse experiences in the active treatment groups were mild or moderate and transient in nature. Thus the foam formulation of clindamycin is a safe and effective acne treatment; the unique foam delivery vehicle may offer cosmetic benefits to the patient and thus increase compliance.     

Pimecrolimus cream 1% can be an effective treatment for seborrheic dermatitis of the face and trunk

The ascomycin macrolactam derivative pimecrolimus is a novel, nonsteroidal, cell-selective inhibitor of inflammatory cytokines specifically developed for the treatment of inflammatory skin diseases. Our objective was to assess the efficacy, tolerability and safety of pimecrolimus cream 1% in the treatment of seborrheic dermatitis. Adults with seborrheic dermatitis of the face and upper trunk who were seen from October 2003 to April 2004 at the Dermatologic Outpatient Clinic of the University of Thrace were enrolled in this 9-week open-label uncontrolled study. Pimecrolimus cream 1% was applied as monotherapy twice daily for 7 days and for an additional period of 7 days thereafter, if needed, until complete clearance was achieved. In cases of recurrence a 5-day course was additionally applied. After screening and an appropriate washout period, subjects were evaluated at baseline (day 0) and at follow-up visits at weeks 1, 3, 6 and 9. The clinical severity of seborrheic dermatitis was estimated as mild (total score 1-3), moderate (total score 4-6) and severe (total score 7-9) in terms of erythema, scaling and lesional extent using a scale from 0 to 3 for each. Patients also assessed their symptoms on a scale from 0 to 5 in terms of the efficacy, safety and tolerability of topical application. Nineteen patients (12 males, seven females) were enrolled in this study. At the end of weeks 1, 3, 6 and 9 the percentages of complete clearance were 63%, 100%, 47% and 52%, respectively. At the end of the study, subjects' average assessment score was 9.73. Apart from topical burning and irritation of the skin in four patients, no other adverse event was mentioned. This pilot study indicates that pimecrolimus applied twice daily can be a safe and efficacious alternative in the treatment of seborrheic dermatitis. Further studies are needed to determine the initial and maintenance therapy.     

Atopic dermatitis: a review of topical treatment options

Abstract

Background:

Atopic dermatitis (AD) is a chronic, pruritic, inflammatory skin disease with a wide range of severity, and is usually the first manifestation of atopic disease. It is one of the most common skin disorders in developed countries, affecting approximately 20% of children and 1–3% of adults. Symptoms such as eczematous papules, plaques, and itch, and their associated consequences, such as sleep disturbance, can significantly impact the quality of life of the patient and family.     

A randomized double-blind,non-inferiority Phase II trial,comparing dapaconazole tosylate 2% cream with ketoconazole 2% cream in the treatment of Pityriasis versicolor

Objectives: The objective of this research was to evaluate the efficacy of a new antifungal imidazole, dapaconazole tosylate, in the treatment of Pityriasis versicolor (PV).

Design and methods: Sixty patients with clinical and mycological diagnosis of PV were randomly assigned to receive either 1 g dapaconazole tosylate 2% cream or 1 g ketoconazole 2% cream. Treatments were applied once a day for 28 days. A dermatologist evaluated efficacy and safety daily, and weekly laboratorial tests were performed. The primary end point was a clinical and mycological cure of lesions after 28 days of treatment. The secondary end point was the time to clinical healing assessed by Kaplan–Meier analysis and Log-rank testing.

Results: Fifty-three patients adhered to protocol rules. Clinical and mycological cure was achieved in 84.6% (22/26) and 92.6% (25/27) of patients treated with ketoconazole and dapaconazole, respectively (difference [effect size] = 8.0%, Standard error of difference: 8.69%, 95% CI: –6.3 to 22.3%). Median time to healing was 23.5 and 21 days for ketoconazole and dapaconazole, respectively (p = 0.126). Adverse events occurred only in ketoconazole-treated patients (13%; 4/30).

Conclusion: Dapaconazole tosylate is non-inferior to ketoconazole when used at a dose of 20 mg/day for 28 consecutive days for the treatment of PV. Dapaconazole also demonstrated a good safety profile.     

Efficacy and safety of azelaic acid (AzA) gel 15% in the treatment of post-inflammatory hyperpigmentation and acne: a 16-week, baseline-controlled study

Although there are few differences in the incidence and pathophysiology of acne across various races and ethnicities, there is some evidence that black patients may have larger sebaceous glands and increased sebum production. Of greater clinical relevance, patients with darker skin types are at increased risk for the development of post-inflammatory hyperpigmentation (PIH), which some find as or more troubling than acne itself. This common and bothersome sequelum of acne can be difficult to manage in this population. Topical azelaic acid gel is recognized to have anti-tyrosinase activity, suggesting it may be a suitable treatment option for mild-to-moderate acne with associated moderate-to-severe PIH. This pilot study demonstrates the efficacy of topical AzA gel 15% when applied twice daily for the reduction of both acne and PIH. J     

Evaluation of the efficacy and tolerance of a topical gel with 4% quassia extract in the treatment of rosacea

BACKGROUND: There are various treatment options available for rosacea, depending on the subtype, but treatment is still generally unsatisfactory. Some studies have reported antiparasitic and anti-inflammatory properties of Quassia amara. AIM: To check the efficacy and safety of a topical gel with 4% Quassia amara extract in the treatment of various grades of rosacea. METHODS: A group of 30 patients with various grades of rosacea (I-IV) were investigated in a single-center, open-label study. They were treated with a topical gel with 4% Quassia amara extract for 6 weeks. Response was evaluated by the flushing, erythema, telangiectasia, papules, and pustules scores. At the end of therapy, overall improvement, safety, and tolerability were assessed. Results: Twenty-seven of 30 patients (90%) completed the study. The treatment resulted to be very effective, and the results achieved were in line with those published with topical metronidazole and azelaic acid. Safety and tolerability were excellent. ConCLUSION: Topical quassia extract could be a new, efficient, and safe weapon in the armamentarium for the management of rosacea.