A double-blind, vehicle-controlled study evaluating masoprocol cream in the treatment of actinic keratoses on the head and neck

Olsen, Elise A.; Abernethy, Margaret; Kulp‐Shorten, Carol L.; Callen, Jeffrey P.; Glazer, Scott D.; Huntley, Arthur C.; McCray, Michael K.; Monroe, Alicia B.; Tschen, Eduardo; Wolf, John E.

doi:10.1016/0190-9622(91)70113-g

Cited by 337 publications

(304 citation statements)

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“…And several smaller retrospective studies gave an indication that change of the immunosuppressive regimen to sirolimus may have a positive effect on the development of NMSCs (13,14,18). (19,26,27,28 (31). On the other hand it is also clear that cyclosporine-treated patients have the same risk of developing NMSC (5,32,33), leading to the conclusion that duration and intensity of the immunosuppression and not specific immunosuppressive agents are the main risk factors for the development of NMSC (6,34,35,36 …”

Section: Nonmelanoma Skin Cancer Is One Of the Most Common Long-term mentioning

confidence: 99%

Switch to a Sirolimus‐Based Immunosuppression in Long‐Term Renal Transplant Recipients: Reduced Rate of (Pre‐)Malignancies and Nonmelanoma Skin Cancer in a Prospective, Randomized, Assessor‐Blinded, Controlled Clinical Trial

Salgo¹,

Goßmann

Schöfer³

et al. 2010

American Journal of Transplantation

205

138

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Renal transplant recipients (RTR) have a 50-200-fold higher risk for nonmelanoma-skin cancer (NMSC) causing high rates of morbidity and sometimes mortality. Cohort-studies gave evidence that a sirolimusbased immunosuppression may inhibit skin tumor growth. This single-center, prospective, assessorblinded, randomized trial investigated if switching to sirolimus treatment inhibits the progression of premalignancies and moreover how many new NMSC occur compared to continuation of the original immunosuppressive therapy. Forty-four RTR (mean age 59.9 years, mean duration of immunosuppression 229.5 months) with skin lesions were randomized to sirolimus or continuation of their original immunosuppression. Blinded dermatological assessment at month 6 and 12 by the same dermatologist evaluated the clinical change compared to baseline. Biopsy was performed in suspected malignancy. Already the 6-month-assessment showed significant superiority of sirolimus-therapy: a stop of progression, even regression of preexisting premalignancies (p < 0.0005). This effect was increased at month 12 (p < 0.0001). Nine patients developed histologically confirmed NMSC: one in the sirolimus group, eight in the control group, p = 0.0176. Sirolimus-based immunosuppression in RTR, even when established many years after transplantation, can delay the development of premalignancies, induce regression of preexisting lesions and decelerate the incidence of new NMSC.

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Section: Nonmelanoma Skin Cancer Is One Of the Most Common Long-term mentioning

confidence: 99%

Switch to a Sirolimus‐Based Immunosuppression in Long‐Term Renal Transplant Recipients: Reduced Rate of (Pre‐)Malignancies and Nonmelanoma Skin Cancer in a Prospective, Randomized, Assessor‐Blinded, Controlled Clinical Trial

Salgo¹,

Goßmann

Schöfer³

et al. 2010

American Journal of Transplantation

205

138

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“…Clinically, AKs are classified by the Olsen grading scheme [17]: AK grade I is slightly palpable (better felt than seen), AK grade II is visible and moderately thick (easily felt and seen), AK grade III is thick and hyperkeratotic (obvious actinic keratosis, felt and seen). Furthermore, AKs are histologically classified based on the Roewert-Huber histological classification system.…”

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confidence: 99%

A review of BF-200 ALA for the photodynamic treatment of mild-to-moderate actinic keratosis

Reinhold¹

2017

Future Oncol.

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BF-200 ALA is a combination of a nanoscale-lipid vesicle formulation and the prodrug 5-aminolevulinic acid (5-ALA). The nanoemulsion stabilizes the prodrug and enhances its penetration through the stratum corneum. It has shown excellent therapeutic results in both lesion and field-directed photodynamic therapy of actinic keratosis (AK). AK is an early form of epidermal neoplasia and a precursor of invasive cutaneous squamous cell carcinoma. It is characterized by the combination of visible neoplastic lesions and surrounding tissue also harboring tumorigenic UV-induced mutations: a concept called field cancerization. A selective, field-directed treatment is ideal to meet the requirements of field change. Here, we review the clinical data on BF-200 ALA for AK along with a summary of molecular mechanisms and future perspectives. Actinic keratosis (AK), also known as solar keratosis, is caused by chronic exposure to sunlight or other ultraviolet light sources [1,2] and may progress to invasive squamous cell carcinoma (SCC) [3]. It is the most common lesion with malignant potential to arise on the skin. AK is mostly seen in Caucasians in skin areas that have extensive sun exposure throughout their lives [4]. Epidemiological data show a high occurrence rate of AK. Regions with higher ultraviolet exposure have a higher prevalence of AK. For the USA, the prevalence was estimated to range from 11 to 26%, while in Australia it ranged from 40 to 60%. In Europe, a prevalence of 15% in men and 6% in women has been documented [5]. Over the age of 70 years, 34% of men and 18% of women were found to have actinic keratotic lesions [6]. Next to fair skin type, an advanced age and lifelong sun exposure immunosuppression/-deficiency plays another important risk factor [5].Mostly, AK develops slowly and early in the disease process, they may disappear only to reappear later. Recurrence of the disease may include partial elimination of the initial lesion, subclinical lesion progression to visible status, or development of new lesions [7]. On top of this, an AK may progress to invasive SCC, the second-most common form of skin cancer [8,9]. The actual percentage of progress to invasive SCC remains unknown, and estimates vary from 5 to 20% within 10 to 25 years with reported annual transformation rates varying greatly from as low as 0.25% to as high as 16% [10]. The regression rate for a single untreated lesion is 15 to 63% after a year; recurrence rates range from 15 to 53% [11]. In general patients develop multiple AKs in one area and predicting which course each individual lesion will follow is impossible. Nonetheless, AK lesions are reliable markers for patients who are most predisposed to developing invasive SCC [4,[12][13].AK lesions typically appear in areas most frequently exposed to the sun such as the face, back of the hands, or bald scalp; 75% of lesions are found on the head, neck and forearms [14]. The lesions vary in appearance as well as size and can include erythematous scaly macules, rough pigmented patches and hyperker...

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“…This Phase 2 study was started in April 2011, before 0.5% 5-FU/SA (Actikerall â ) received regulatory approval in Europe in 2011 for its 12-week dosing schedule and indication for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic AKs (grade I/II according to the 4-point scale of Olsen et al 20 ) in immunocompetent adult patients. Thus, a reduced dosing schedule and small sample size, alongside the inclusion of more difficult-to-treat AKs, i.e.…”

Section: Discussionmentioning

confidence: 99%

“…There were no significant differences in lesion location between the treatment groups. Most (74.5%) AKs were grade II, and 25.5% were grade III according to the criteria of Olsen et al 20 ( Table 2).…”

Section: Aksmentioning

confidence: 99%

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A prospective randomized exploratory study comparing the efficacy of once‐daily topical 0.5% 5‐fluorouracil in combination with 10.0% salicylic acid (5‐FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis

Simon

Dominicus

Karl³

et al. 2014

Acad Dermatol Venereol

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A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis Mean change in lesion count from baseline to Day 98 was À5.2 and À5.7 lesions per patient for 0.5% 5-FU/SA and cryotherapy groups respectively. Histological AK clearance rates on Day 98 were 62.1% and 41.9% respectively. At 6-month posttreatment follow-up, recurrence of cleared lesions (no clinically visible lesions in treatment area) occurred in 39.4% of 0.5% 5-FU/SA and 84.8% of cryosurgery patients. Drug-related adverse events (AEs), including local skin reactions considered 'severe' by the investigator, were reported in 24.2% of 0.5% 5-FU/SA and 6.1% of cryosurgery patients. All drug-related AEs were skin reactions.Conclusions Although the study was not powered to explore statistical differences in clinical efficacy between treatments, a short (6-week) schedule of topical treatment with 0.5% 5-FU/SA achieved greater histological clearance and lower recurrence of grade II/III hyperkeratotic AKs than cryosurgery. AE incidence across both treatment groups was relatively low and AEs were generally mild or moderate. Clinical trials.gov identifier: NCT01358851.

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A double-blind, vehicle-controlled study evaluating masoprocol cream in the treatment of actinic keratoses on the head and neck

Cited by 337 publications

References 4 publications

Switch to a Sirolimus‐Based Immunosuppression in Long‐Term Renal Transplant Recipients: Reduced Rate of (Pre‐)Malignancies and Nonmelanoma Skin Cancer in a Prospective, Randomized, Assessor‐Blinded, Controlled Clinical Trial

Switch to a Sirolimus‐Based Immunosuppression in Long‐Term Renal Transplant Recipients: Reduced Rate of (Pre‐)Malignancies and Nonmelanoma Skin Cancer in a Prospective, Randomized, Assessor‐Blinded, Controlled Clinical Trial

A review of BF-200 ALA for the photodynamic treatment of mild-to-moderate actinic keratosis

A prospective randomized exploratory study comparing the efficacy of once‐daily topical 0.5% 5‐fluorouracil in combination with 10.0% salicylic acid (5‐FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis

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