Tildrakizumab in Combination With Topical Halcinonide 0.1% Ointment for Treating Moderate to Severe Plaque Psoriasis.

BACKGROUND: This prospective, open-label study evaluated the effectiveness and safety of tildrakizumab plus topical halcinonide ointment in psoriasis patients. METHODS: Adults (age greater than or equal to 18 years) with moderate to severe plaque psoriasis (body surface area [BSA] greater than or equal to 10%, physician's global assessment [PGA] greater than or equal to 3, psoriasis area severity index [PASI] greater than or equal to 12) received tildrakizumab (100 mg; s.c.) at weeks 0, 4, and 16. Patients with BSA >3% at week 16 received additional halcinonide 0.1% twice daily for 4 weeks (week 20) and were followed for another 4 weeks (week 24); those with BSA less than or equal to 3% were followed to week 24. RESULTS: Twenty-five patients were enrolled (mean age 52.6 years; 68% male). The proportion of all patients achieving BSA less than or equal to 3% was 52.2% at week 16, 73.7% at week 20 (after 4 weeks of adjunctive halcinonide in patients with BSA >3% at week 16), and 84.2% at week 24 (4 weeks after halcinonide discontinuation). PASI 75 was attained in 60.9% of all patients at week 16, and 73.7% at weeks 20 and 24. In patients adding halcinonide, improvements from baseline in mean BSA, PGA, and PGA x BSA increased from week 16 (55%, 29%, and 64%, respectively) to week 20 (78%, 51%, and 88%, respectively), and were maintained through week 24. Quality of life improved with tildrakizumab monotherapy and further with adjunctive halcinonide. Adverse events (AEs) were infrequent. No serious AEs or discontinuations due to AEs were noted. CONCLUSION: Tildrakizumab plus topical halcinonide ointment is safe and effective in controlling psoriasis for patients inadequately responding to tildrakizumab monotherapy.Bagel J, Novak K, Nelson E. Tildrakizumab in combination with topical halcinonide 0.1% ointment for treating moderate to severe plaque psoriasis. J Drugs Dermatol. 2023;22(8):766-772. doi:10.36849/JDD.6830.

The efficacy of high-intensity, focused ultrasound treatment for non-neoplastic epithelial disorders of the vulva.

Non-neoplastic epithelial disorders of the vulva (NNEDV) are common types of vulval lesions. Although corticosteroids represent a first-line treatment for NNEDV, concerns exist about the safety associated with long-term topical corticosteroid use. Recently, several clinical trials have identified high-intensity focused ultrasound (HIFU) as a promising treatment modality for NNEDV. The aim of this multi-center, randomized, controlled clinical trial was to investigate the efficacy of HIFU therapy in women with NNEDV based on histological alterations. We enrolled patients who were clinically diagnosed with NNEDV. They were randomized into 2 treatment groups: 1) halcinonide for 3 months or 2) HIFU once. A total of 123 patients were biopsied both prior to and after the therapy, and 62 and 61 patients were assigned to the HIFU and halcinonide groups, respectively. The histological changes were then analyzed. After the treatments, the therapeutic effects were observed in both groups. Comparing the diagnosis and alterations in lichenoid and sclerotic patterns and in chronic inflammation, we found statistically significant differences. Furthermore, when compared with the halcinonide group, the HIFU group exhibited enhanced curative effects that were statistically significant (P = 0.039). Based on the histological evidence from this randomized, controlled trial, HIFU represents an effective method for the treatment of NNEDV.

[Multicenter randomized clinical study of high-intensity focused ultrasound and cortical hormone in the treatment of non-neoplastic epithelial disorders of vulva].

OBJECTIVE: To evaluate the efficacy of high-intensity focused ultrasound (HIFU) and cortical hormone in the treatment of non-neoplastic epithelial disorders of vulva. METHODS: A total of 268 cases with pathologically diagnosed non-neoplastic epithelial disorders of vulva were randomly allocated into two groups of high-intensity focused ultrasound (HIFU) (n = 119) and cortical hormone (n = 124). And 25 cases became lost to follow-ups. Their signs, symptoms and quality-of-life were assessed before treatment, 1 month post-treatment and 3 months post-treatment. And the relationship was analyzed between pathologic type, age, course and efficacies. RESULTS: Their signs, symptoms and quality-of-life improved in both groups after 1 and 3 month. Compared with drug therapy, HIFU showed superior results in lesion amelioration at 1 month with significantly statistical difference and so did lesion amelioration and therapeutic effect at 3 month. And the efficacy of HIFU was better in those with >10-year disease course and pathologically diagnosed lichen sclerosus in 3 months. CONCLUSIONS: HIFU is both safe and effective in the treatment of non-neoplastic epithelial disorders of vulva.

Avaliaçäo terapêutica da halcinonida creme e pomada em pacientes portadores de dermatoses: aplicaçäo única diária / Therapeutic evaluation of halcinonide both crems and ointments in patients with dermatoses: a single darly use

Trinta e três pacientes portadores de dermatoses, na maioria eczematosas, foram submetidos a terapêutica tópica com creme ou pomada de halcinonida a 0,1% oclusivo, por um período de uma a quatro semanas. A avaliaçäo da eficácia da droga foi baseada em critérios objetivos e subjetivos, tendo havido de modo concordância ente ambos. Os resultados foram excelentes em 28 casos (85%), bons em quatro e regular em um único caso. Näo houve relato de evidência de efeitos colaterais importantes. Este novo esquema terapêutico quer pelos resultados observados como pela aceitaçäo por parte do paciente frente a comodidade de uma aplicaçäo diária

Avaliaçäo da eficácia da halcinonida em aplicaçäo tópica diária única, näo oclusiva em dermatite de contato / Evaluation of the efficacy of halcinonide in the topical once daily dosage administration without occlusive dress in contact dermatitis

Trinta pacientes portadores de dermatite contato em fases aguda e subaguda forma submetidos a tratamento tópico com creme de halcinonida a 0,1% empregando uma única aplicaçäo diária do fármaco, sem penso oclusivo. As afecçöes foram consideradas como de intensidade moderada em 27 casos (90%), sendo que nove pacientes já haviam recebido tratamento anteriores para esta patologia. A eficácia da terapêutica foi avaliada de forma subjetiva e objetiva por meio de controles semanais por um período máximo de quatro semanas. O resultado final foi considerado satisfatório em 93,34% dos casos (28 pacientes classificados como avaliaçäo excelente e boa) e regular em apenas dois casos (6,66%). Näo se observaram reaçöes de hipersensibilidade ou irritaçäo local em nenhum dos casos. A terapêutica, em aplicaçäo única diária, demonstrou excelentes resultados aliados à facilidade de aplicaçäo e insençäo de efeitos adversos

Avaliaçäo da eficácia terapêutica da soluçäo de halcinonida a 0,1% em dermatoses crônicas / Evaluation of therapeutic efficaccy of halcinonide cream 0,1% in chronic dermatoses

Os autores apresentam uma avaliaçäo terapêutica com uma soluçäo alcoólica de Halcinonida a 0,1%, ácido salicílio a 2% e cloreto de benzoxônio a 0,1% em 36 pacientes portadores de dermatoses crônicas (Dermatite Seborréia 34 e Psoríase 2). Levou-se em consideraçäo o sexo, a intensidade do quadro dermatológico (Grave, moderado e leve), o prurido e o eritema. A avaliaçäo dos resultados foi feita levando-se em conta critérios subjetivos (opiniäo do paciente) e objetivos (exame dermatológico). Dos 36 pacientes, 22 (61%) eram do sexo masculino e 14 (39%) do sexo feminino, Do total de paciente, 21 (58%) apresentavam lesöes leves, 14 (39%) lesöes de intensidade moderada e apenas 1 (3%) apresentava quadro grave. Os pacientes foram orientados a fazer uma aplicaçäo tópica diária da soluçäo, por um período máximo de 28 dias e avaliados semanalmente (7§, 14§, 21§ e 28§ dia). Todos os pacientes apresentaram prurido e eritema. Tanto a avaliaçäo subjetiva quanto a objetiva procurou enquadrar o paciente em um dos três de resultado: Excelente, Bom e Regular. Dos 36 pacientes, 20 (55,5%) apresentaram resultados excelentes, 9 (25%) resultados bons e 7 (19,5%) resultados regulares, no critério objetivo de avaliaçäo. No critério subjetivo da avaliaçäo 23 (64%) foram enquadrados como resultados excelentes, 10 (28%) resultados bons e 3 (8%) resultados regulares. Os resultados foram melhores nas formas leves (76% dos resultados excelentes e 19% de bons). O prurido na forma leve desapareceu em 66% dos casos na primeira semana; na forma moderada 64% somente apresentaram o desaparecimento do prurido após a primeira semana. Quanto aos efeitos colaterais, observou-se na vigência do tratamento 3 casos (8%) de foliculite. A terapêutica com a soluçäo de halcinonida a 0,1% em amplicaçäo diaria única, evidenciou excelentes resultados sobre os principais sintomas das dermatoses - prurido e eritema - representando em boa opçäo no tratamento das dermatites seborréicas de couro cabeludo e de áreas pilosas

Ensaio terapêutico com o emprego da soluçäo de halcinonida a 0,1% em dermatite seborréica do couro cabeludo / Therapeutic trial with the use of halcinonide solution at 0,1% in seborrhea dermatitis of the scalp

Os autores apresentam ensaio clínico terapêutico com uma soluçäo de Halcinonida a 0,1%, ácido salicílico a 2% e cloreto de benzoxônio a 0,1% em veículo alcoólico, nos casos leves e moderados de dermatite seborréica do couro cabeludo, em 100 pacientes de ambos os sexos. A terapêutica, em aplicaçäo única diária, demonstrou excelentes resultados sobre os sintomas da afecçäo (prurido, descamaçäo e eritemia). Näo produziu modificaçäo da condiçäo seborréica inerente à funçäo glandular de cada paciente

A comparative study of amcinonide and halcinonide in the treatment of eczematous dermatitis.

Thirty-three patients with acute or subacute eczematous dermatitis were treated for two weeks in a double-blind, parallel-group study to compare the efficacy and cosmetic acceptability of 0.1 percent amcinonide cream and 0.1 percent halcinonide cream. Patients in both treatment groups showed significant (p less than 0.05) improvement from baseline for most signs and symptoms at the three evaluation times (days 3, 7, and 14). Comparisons between groups showed no significant differences at any evaluation except at day 14, when the amicinonide-treated patients had significantly (p = 0.04) less edema. The physician's evaluations were not significantly different except at day 7, when the halcinonide patients showed significantly (p = 0.04) more overall improvement. The patients' overall evaluations were not significantly different at any time. In general, both creams were cosmetically acceptable. At day 3, seven amcinonide patients noted skin tightening compared to one halcinonide patient; four halcinonide patients (as well as two at day 7 and one at day 14) reported stinging compared to only one amcinonide patient. In addition, two halcinonide patients reported a burning sensation at one or more evaluations compared to no such reports from amcinonide patients. One other side effect, a metallic taste in the mouth, occurred in a halcinonide-treated patient.

Efficacy versus systemic effects of six topical steroids in the treatment of atopic dermatitis of childhood.

Six groups of children suffering from widespread atopic dermatitis were treated once daily with six topical steroids of different potency. Systemic effects were measured by the morning estimation of plasma cortisol. A clear relationship was demonstrated between clinical efficacy of the steroid treatment and degree of reduced adrenal function. This study demonstrated that a rapid and marked therapeutic effect can be obtained with potent topical steroids applied once daily without occlusion, but in children is accompanied by a fall in plasma cortisol.

The use of halcinonide solution, 0.1 percent, in the treatment of eczematous diseases.

Halcinonide solution, 0.1 percent, was used to treat sixty-six patients with eczematous dermatoses. The majority of the responses were excellent, with the condition clearing completely in eight patients within the first week. The total mean amount of medication used by each patient for twice a day application for one or two weeks was less than 24 ml.

Short-term topical corticosteroid therapy (halcinonide ointment) in the management of atopic dermatitis.

The efficacy of short-term treatment of acute exacerbations of atopic dermatitis with a corticosteroid ointment (halcinonide, 0.1 percent) was demonstrated by comparing such a formulation with its ointment base (placebo). A double-blind, paired comparison study was conducted in 214 patients. Within two weeks the therapeutic response was judged excellent in 137 (64 percent) of the patients receiving the corticosteroid treatment. The number of responses judged good to excellent was 182 (85 percent). With the placebo, there was an excellent response in 50 (23 percent) of the patients and the number judged good to excellent was 95 (44 percent). Although these placebo responses attested to the appropriateness of a highly occlusive ointment vehicle in this condition, the corticosteroid containing formulation was superior (p less than 0.001). In only 10 (5 percent) of the patients was there a poor response to corticosteroid treatment. direct comparison of the response of similar bilateral lesions showed the corticosteroid to be superior to the placebo in 147 (69 percent) patients and the placebo to be superior in just 31 (15 percent) (p less than 0.001). No adverse reactions occurred with either preparation. We conclude that in the management of atopic dermatitis, full advantage should be taken of short-term corticosteroid therapy (preferably in ointment form), which is virtually free of those potential unwanted effects of chronic therapy with this class of drugs.

Evaluation of a new halcinonide formulation in the treatment of common dermatoses.

An open evaluation of halcinonide 0.1 percent in a hydrophilic vanishing cream base was conducted in one hundred patients with common steroid-responsive dermatoses, including eczema, contact dermatitis, atopic dermatitis stasis dermatitis, and neurodermatitis. Patients applied the cream two or three times a day for two weeks (or less if the clinical response warranted earlier discontinuation). Follow-up assessments were made on days 4, 7, and 14 of the study. Ninety-eight percent of the patients showed some degree of improvement, and eighty-five percent had complete clearing or marked improvement. One patient had no response and one worsened. Seventy-seven percent of the patients who responded achieved their maximum response within the first week of treatment. One case of urticaria was the only side effect noted in this series. Ninety-six percent of the patients rated their acceptance of the new formulation as excellent or good.

A controlled comparison of amcinonide cream 0.1 percent and halcinonide cream 0.1 percent in the treatment of eczematous dermatitis.

A 2-week, double-blind clinical trial was conducted to compare the efficacy and cosmetic acceptability of amcinonide cream 0.1 percent and halcinonide cream 0.1 percent in the treatment of 29 patients with eczematous dermatitis. The dermatologic status of each patient was rated by improvement in clinical signs and symptoms, by the investigator's overall evaluation, and by two patient evaluations. Both medications produced statistically significant and equivalent improvement by Week 2. However, amcinonide was significantly favored in the efficacy evaluation of relief from burning pain at Week 2 and in patient acceptability evaluations in regard to the absence of burning, stinging, and itching on application. The role of propylene glycol in the formulation of the halcinonide cream as a contributing cause of irritation is noted.

Efficacy of halcinonide cream, 0.1 percent, in the treatment of moderate and severe dermatoses.

The efficacy of halcinonide cream, 0.1 percent, was evaluated in 101 patients with moderate or severe dermatoses. Conditions of these patients included contact dermatitis, atopic dermatitis, nummular eczema, neurodermatitis, stasis dermatitis, dyshidrosis, and various combinations of these disorders. Halcinonide cream was prescribed twice or three times a day for three weeks, and patients were followed-up weekly during this period. Sixteen patients stopped treatment after two weeks because their lesions had cleared. By the end of three weeks, the condition in 46 of the patients had completely resolved, the condition in 39 showed marked improvement, the condition in 10 had improved moderately, the condition in 5 showed mild improvement, and the condition in 1 did not show any improvement. No local or systemic side effects were reported. We conclude that halcinonide cream is an effective and safe topical therapy in the short-term treatment of a variety of moderate to severe steroid-responsive dermatoses.

Low concentration halcinonide cream in the topical management of atopic dermatitis in pediatric patients.

Seventy-nine patients with atopic dermatitis were treated in a double-blind paired comparison fashion with halcinonide cream (0.025%) or its placebo control. The overall therapeutic response was excellent in thirty-seven (47%) patients treated with halcinonide cream (0.25%) as compared with twenty-two (28%) patients treated with the placebo cream. In the comparative response, halcinonide was considered superior in forty-six (58%) patients, and the placebo was considered superior in fifteen (19%). Statistically, halcinonide cream was shown to be significantly superior to the placebo cream (p less than 0.001). Side effects noted in five patients included burning, stinging, and pain, due in most cases to both halcinonide and the placebo cream.

Treatment of psoriasis and atopic dermatitis with halcinonide cream applied once and three times daily.

In a double-blind multi-centre study, comprising ninety-five patients with psoriasis and atopic dermatitis, 0.1% halcinonide cream applied once daily was equally as effective as the cream applied three times daily. However, the onset of action was more rapid when the cream was applied three times daily. In a control study once daily application of 0.1% halcinonide cream was found to be superior to the vehicle alone in the treatment of forty patients with the same diseases.

Palmar-plantar lichen sclerosus et atrophicus.

A 57-year-old woman has had lichen sclerosus et atrophicus confined to the palms and soles for the past six years. Diagnosis was confirmed by histologic study. Our patient's disease has been resistant to therapy.