A Step Toward Standardizing Clinical Trials of Actinic Keratosis

Gupta, Aditya K.; Martin, George M.; Renaud, Helen J.

doi:10.1001/jamadermatol.2019.4210

Cited by 3 publications

(2 citation statements)

References 15 publications

(18 reference statements)

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Section: Topical Treatment Efficacy Assessmentmentioning

confidence: 99%

“…Regulatory agencies require assessment of the CCR of AK lesions as a key clinical trial outcome for the definition of short-term efficacy (4-12 weeks) (26). However, there are concerns that this "all or nothing" outcome measure is often unattainable, and therefore is too rigorous and may undervalue some effective treatments, particularly in patients with large-field disease where it is more difficult to achieve complete clearance (26). As a result, some dermatologists have recommended using absolute or percentage reductions in lesion counts, rather than using binary endpoints, such as CCR, to assess treatment efficacy in clinical practice (21,27).…”

Section: Topical Treatment Efficacy Assessmentmentioning

confidence: 99%

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Evaluating the Efficacy and Safety of 4% 5-Fluorouracil Cream in Patients with Actinic Keratosis: An Expert Opinion

Stockfleth,

Heppt,

Bégeault

et al. 2023

Acta Derm Venereol

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Actinic keratosis is a lesion that develops in sun-exposed areas of the skin and is considered to be a precancerous condition or an early in situ squamous cell carcinoma. Treatment of actinic keratosis is important for reducing skin cancer risk, with treatment choice based on patient-, lesion- and treatment-related considerations. Of the topical treatments used for field-directed therapy, those containing 5-fluorouracil are among the most effective and widely prescribed. The most recently developed topical 5-fluorouracil preparation (Tolak®; Pierre Fabre, France) contains 4% 5-fluorouracil in an aqueous cream. This narrative review discusses data on 4% 5-fluorouracil cream to treat actinic keratosis, and provides the authors’ expert opinion on issues associated with it use. The effect of the cream has been evaluated in phase 2 and 3 trials of adult patients with actinic keratosis on the face, ears or scalp. These trials included patients with severe baseline disease, defined by high lesion counts and large-size treatment fields, which possibly affected the proportion of patients who were able to achieve complete clearance. Other efficacy parameters (e.g. percentage change in lesion count, ≥ 75% clearance of lesions or clinically significant changes in validated severity scales) should also be assessed to fully evaluate 4% 5-fluorouracil treatment efficacy in these patients. Nevertheless, 4% 5-fluorouracil is associated with high efficacy, a low level of recurrence and a satisfactory safety profile.

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Section: Topical Treatment Efficacy Assessmentmentioning

confidence: 99%

Section: Topical Treatment Efficacy Assessmentmentioning

confidence: 99%

Evaluating the Efficacy and Safety of 4% 5-Fluorouracil Cream in Patients with Actinic Keratosis: An Expert Opinion

Stockfleth,

Heppt,

Bégeault

et al. 2023

Acta Derm Venereol

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Comparison of therapeutic agents' short‐term effects on facial and scalp actinic keratosis: A network meta‐analysis

Gupta,

Bamimore,

Wang

et al. 2024

J of Cosmetic Dermatology

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BackgroundCare for actinic keratosis (AK) can be improved with more knowledge on the relative of effect of indicated therapies.ObjectivesUsing network meta‐analyses, we quantitatively determined the comparative “short‐term” effects of interventions in adults with facial and scalp AK.MethodsOn February 28, 2023, evidence from the peer‐reviewed literature was systematically obtained from OVID, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov. We analyzed data from studies published in English, of a trial design, and investigating the effect of an actinic keratosis monotherapy. Patient complete clearance, patient partial clearance or lesion‐specific clearance across adults were analyzed at 8–12 weeks after therapy. Patient complete clearance pertained to proportion of participants who experienced complete clearance of actinic keratosis lesions; patient partial clearance corresponded to percentage of subjects who achieved at least 75% clearance of actinic keratosis lesions; lesion‐specific clearance represented the percentage of all lesions that were cleared. In the main (i.e., base) analyses, nodes were analyzed only at the level of the agent.ResultsData from a total of 84 studies were used—across which 22 active agents were identified. Estimates of interventions' surface under the cumulative ranking curve rankings and (pairwise) relative effects were estimated. Across the three outcomes, fluorouracil 5% was ranked the most effective.ConclusionsOur work is the first to provide information on covariate‐adjusted relative effects of actinic keratosis therapies— including the more recently reported treatments—for the face and scalp; this knowledge may help physicians and patients make more informed decisions.

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Features of interpretation of data of light and spectral dermatoscopy in patients with actinic keratosis

Теплюк¹,

Прокоф’єва²,

Zapolsky³

et al. 2021

УЖДВК

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Actinic keratosis (AK) is a common disease that is formed as a result of excessive insolation of exposed skin areas. One of the possible options for the development of the disease is the transformation of AK into squamous cell carcinoma. The timely diagnosis of suspicious areas of AK with their subsequent excision and histological examination has great importance in the prevention of neoplastic transformations of the skin.The aim of our study was to identify dermatoscopic patterns of the initial stages of neoplastic transformation of actinic keratosis and a comparative analysis of the diagnostic effectiveness of digital dermatoscopy, twocolor spectral dermatoscopy in relation to histological examination in a group of individuals suffering from actinic keratosis.There were 49 patients with AK under our supervision. All suspected cases of keratosis were additionally examined histologically. We analyzed the features of clinical forms and modified existing diagnostic methods. To expand the diagnostic capabilities of standard dermatoscopy, studies were performed in different ranges of light. Spectral dermatoscopy allowed estimating the potential foci of neoplastic transformation in blue and green light field (standard illumination range was suppressed). Particular attention was paid to areas of increased keratinization, areas of excessive vascularization with a predominance of superficial capillary network, microulcers with loose edges that contrast well with the green spectrum, as well as dynamic changes in color in one field of study for 30 days.It was found that the use of spectral dermatoscopy increases the diagnostic capabilities of AK and allows identifying more accurately the early signs of neoplastic transformations associated with both pathological neoangiogenesis («strawberry» pattern, glomerular network) and pathological proliferation (pseudogranulations, pathological keratinization, etc.).

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A Step Toward Standardizing Clinical Trials of Actinic Keratosis

Cited by 3 publications

References 15 publications

Evaluating the Efficacy and Safety of 4% 5-Fluorouracil Cream in Patients with Actinic Keratosis: An Expert Opinion

Evaluating the Efficacy and Safety of 4% 5-Fluorouracil Cream in Patients with Actinic Keratosis: An Expert Opinion

Comparison of therapeutic agents' short‐term effects on facial and scalp actinic keratosis: A network meta‐analysis

Features of interpretation of data of light and spectral dermatoscopy in patients with actinic keratosis

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