Long-term clinical outcomes of imiquimod 5% cream vs. diclofenac 3% gel for actinic keratosis on the face or scalp: a pooled analysis of two randomized controlled trials.

BACKGROUND: Actinic keratosis (AK) is an early in situ epidermal cancer which can progress to invasive squamous cell carcinoma (SCC). Imiquimod 5% cream (IMIQ) and diclofenac 3% gel (DIC) are frequently used to treat AK; however, their long-term effects following repeated treatment cycles have never been compared. OBJECTIVE: To compare IMIQ and DIC in the treatment of AK with respect to the risk of change to grade III AK or invasive SCC, after 3 years. METHODS: Data were pooled from two randomized, active-controlled, open-label, multicentre, multinational, phase IV studies (Clinicaltrials.gov NCT00777127/NCT01453179), with two parallel groups. Studies were conducted between 2008 and 2015 and were almost identical in design. Patients eligible for inclusion were immunocompetent adults with 5-10 visible AK lesions on the face/scalp and grade I/II AK. The primary endpoint was inhibition of histological change to grade III AK or invasive SCC in the study treatment area, observed until month 36. Patients applied either IMIQ or DIC for a maximum of six treatment cycles. RESULTS: In total, 479 patients (IMIQ 242; DIC 237) were included in the full analysis set. Histological change to grade III AK or invasive SCC was observed until month 36 in 13 (5.4%) patients treated with IMIQ, compared with 26 (11.0%) patients treated with DIC (absolute risk difference -5.6% [95% confidence interval -10.7%, -0.7%]). Time to histological change was greater in the IMIQ group than the DIC group (P = 0.0266). Frequency of progression to invasive SCC was lower with IMIQ than with DIC at all time points. Initial clearance rate was higher in the IMIQ group compared with the DIC group, while recurrence rate was lower. Both treatments were well tolerated. CONCLUSIONS: Over 3 years, IMIQ was superior to DIC in clearing AK lesions and preventing histological change to grade III AK or invasive SCC and recurrence.

Topical 3.0% diclofenac in 2.5% hyaluronic acid gel induces regression of cancerous transformation in actinic keratoses.

BACKGROUND: Actinic keratoses (AKs) are frequently diagnosed in dermatological patients. As they represent in situ carcinomas, effective treatment is required. OBJECTIVES: We investigated the effect of topical 3.0% diclofenac in 2.5% hyaluronic acid gel on AK. METHODS: Sixty-five patients with AKs were clinically evaluated before and after 3 months' treatment with topical 3.0% diclofenac in 2.5% hyaluronic gel. Biopsy specimens were taken and stained with haematoxylin-eosin and immunohistological markers. Specimens were evaluated for histological type of AKs using the AK classification scheme suggested by Röwert-Huber et al. [(early) in situ squamous cell carcinoma type AK Grade I-III], number of mitoses per high-power field and expression of immunohistological markers. RESULTS: Complete clinical resolution was observed in 11 patients (16.9%). A significant (P<0.001) downgrading of AK grade was observed. Complete histological resolution was achieved in 15 patients (23.1%). The number of mitoses per high-power field was reduced significantly (P<0.001). The expression of anti-p53-antibody decreased significantly (P=0.009), as did the expression of anti-MiB-1 antibody (P=0.021). CONCLUSIONS: 3.0% diclofenac in 2.5% hyaluronic acid gel causes regression of signs of cancerous transformation after 3 months' therapy.

[Surgical correction of scleroderma en coup de sabre]. / Operative Korrektur einer Sklerodermie en coup de sabre durch En-bloc-Resektion.

A 15-year-old patient developed scleroderma en coup de sabre on right temple at 5 years of age. Multiple treatments (3 cycles of intravenous penicillin, topical glucocorticosteroids, topical calcipotriol, and cream PUVA phototherapy combined with topical calcipotriol) produced no improvement. The patient suffered greatly from the psychosocial stigmatization, so that the entire lesion was resected at 14 years of age. One year after the operation a thin non-sclerotic scar was present; tiny lateral areas of sclerosis not included in the operative field were unchanged. The operation greatly improved the patient's daily life. The surgical therapy of scleroderma en coup de sabre offers an interesting therapeutic alternative.

[Bleomycin-induced PSS-like pseudoscleroderma. Case report and review of the literature]. / Bleomycin-induzierte PSS-artige Pseudosklerodermie. Fallbericht und Revision der Literatur.

Although the association between administration of the antitumor agent bleomycin and the development of cutaneous fibrosis is established, there are only a small number of cases of bleomycin-induced scleroderma described in the literature. We report the development of generalised scleroderma with wide spread hyperpigmentation in a 52-year-old male patient, who received a total dose of 360 mg bleomycin in combination with cisplatin and etoposid for therapy of a malignant testicular seminoma. The clinical cutaneous alterations as well as the histological findings were indistinguishable from those encountered in progressive systemic sclerosis (PSS). In contrast to PSS however, Raynaud's phenomenon, cutaneous calcinosis, teleangiectasia, arthritis and involvement of additional organs were all absent. PSS-typical auto-antibodies were negative. Even 18 months after discontinuation of the drug and treatment with UVA1 phototherapy (3-4 times per week with 20 J/cm2) as well as physiotherapy, the skin changes had still not resolved. Based on our case and a detailed review of the literature, we discuss characteristics of bleomycin-induced scleroderma including pathogenesis, treatment modalities and course.

Low-dose UVA phototherapy for treatment of localized scleroderma.

BACKGROUND: For treatment of localized scleroderma numerous treatments, including ones with potentially hazardous side effects, are currently used with only limited success. OBJECTIVE: We attempted to determine the efficacy of low-dose UVA1 irradiation in patients with severe localized scleroderma. METHODS: Patients were irradiated with 20 J/cm2 UVA1 for 12 weeks (total number of treatments: 30; cumulative UVA1 dose: 600 J/cm2). RESULTS: Low-dose UVA1 irradiation induced significant clinical improvement (clearance of > 80% of lesions) in 18 of 20 patients. Clearance was documented by clinical score as well as by 20 MHz ultrasound and histopathologic analysis. CONCLUSION: Low-dose UVA1 phototherapy can be highly effective for sclerotic plaques, even in patients with advanced localized scleroderma and with lesions rapidly evolving despite conventional therapy.

[The successful monotherapy of hypereosinophilic dermatitis with PUVA-bath photochemotherapy]. / Erfolgreiche Monotherapie der hypereosinophile Dermatitis mit PUVA-Bad-Photochemotherapie.

A 70-year-old woman with long-standing hypereosinophilic dermatitis improved strikingly with PUVA-bath photochemotherapy. The single UVA doses ranged from 0.3 to 3.3 J/cm2. After 19 treatment sessions pruritus disappeared, and after 32 treatments the erythematous maculae completely cleared. Under continuous treatment three times a week, no relapse has occurred to date. PUVA-bath photochemotherapy seems to be a promising new treatment modality without systemic side effects for patients with hypereosinophilic dermatitis.

Contact allergy to 8-methoxypsoralen.

A 36-year-old female patient was treated with PUVA for dyshidrotic eczema that had not shown sufficient response to topical therapy over the previous months. PUVA therapy caused acute aggravation of the eczema. Patch testing demonstrated Type IV sensitization to 8-methoxypsoralen in Meladinine solution.