Topical diclofenac in hyaluronan gel for the treatment of solar keratoses

Gebauer, Kurt; Brown, Pam; Varigos, George

doi:10.1046/j.1440-0960.2002.00635.x

Cited by 85 publications

(69 citation statements)

References 11 publications

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“…This situation was recently reported with a different topically applied COX inhibitor in an actinic keratosis trial (57)(58)(59)(60). When the unmodified COX inhibitor, diclofenac, was used to treat actinic keratosis lesions, it found to be ineffective.…”

Section: Discussionsupporting

confidence: 62%

“…The labeled drug was now found to partition in the vicinity of basal cells at the basement membrane. Diclofenac formulated with hyaluran was found to be much more efficacious in reversing actinic keratoses as demonstrated in a subsequent randomized trial, which led to Food and Drug Administration approval for use in the treatment of actinic keratosis (57)(58)(59)(60)(61)(62).…”

Section: Discussionmentioning

confidence: 98%

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Randomized, Double-Blind, Placebo-Controlled Phase IIB Trial of the Cyclooxygenase Inhibitor Ketorolac as an Oral Rinse in Oropharyngeal Leukoplakia

Mulshine¹,

Atkinson

Greer

et al. 2004

Clinical Cancer Research

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Purpose: Nonselective cyclooxygenase (COX) inhibitors have been reported to decrease the frequency of upper aerodigestive cancers. Ketorolac tromethamine oral rinse has been shown to resolve another COX-dependent process, periodontal disease, without incurring gastrointestinal side effects. This trial evaluated if a topically delivered oral rinse containing ketorolac was as safe as and more effective than oral rinse alone in reducing the area of oral leukoplakia.Experimental Design: 57 patients were randomized (2:1 ratio) in a double-blind, placebo-controlled study of ketorolac (10 ml of a 0.1% ketorolac rinse solution; n ‫؍‬ 38) or placebo (10 ml of rinse solution; n ‫؍‬ 19) given twice daily for 30 s over 90 days. Primary end point was evaluated visually obtaining bidimensional measurement of the size of leukoplakia lesion(s) at entry and at 90 days. Secondary end point was histological assessment of the leukoplakia as sampled by serial punch biopsy and independently reviewed by three pathologists.Results: The patients included 67% males, 11% nonCaucasian, and 86% used tobacco with no significant differences between the two arms. Both rinses were well tolerated with good compliance, and there was no significant difference in adverse events (P ‫؍‬ 0.27). Major response rate (complete response and partial response) was 30% for ketorolac and 32% for the placebo arm. There was no significant difference in change in histology between the two arms.Conclusion: Local delivery of a COX-containing oral rinse was well tolerated but produced no significant reduction in the extent of leukoplakia compared with the placebo. However, the favorable response rate to placebo arm remains unexplained and additional investigation of the tissue penetration with ketorolac is warranted.

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Section: Discussionsupporting

confidence: 62%

Section: Discussionmentioning

confidence: 98%

Randomized, Double-Blind, Placebo-Controlled Phase IIB Trial of the Cyclooxygenase Inhibitor Ketorolac as an Oral Rinse in Oropharyngeal Leukoplakia

Mulshine¹,

Atkinson

Greer

et al. 2004

Clinical Cancer Research

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“…The overall lesion clearance rates of 54-63% reported in RCTs (84,85) are rarely observed in real-life clinical practice. However, an advantage of diclofenac is its good tolerability with only mild irritant side effects such as pruritus, erythema and dry skin, and only rare occurrences of contact dermatitis (60,(84)(85)(86)(87).…”

Section: J U S T a C C E P T E D Diclofenac 3% In 25% Hyaluronic Acidmentioning

confidence: 98%

Real-world approach to actinic keratosis management: practical treatment algorithm for office-based dermatology

Dirschka

Gupta

Micali

et al. 2016

Journal of Dermatological Treatment

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Actinic keratosis (AK) is a chronic skin disease in which multiple clinical and subclinical lesions co-exist across large areas of sun-exposed skin, resulting in field cancerisation. Lesions require treatment because of their potential to transform into invasive squamous cell carcinoma. This article aims to provide office-based dermatologists and general practitioners with simple guidance on AK treatment in daily clinical practice to supplement existing evidence-based guidelines. Novel aspects of the proposed treatment algorithm include differentiating patients according to whether they have isolated scattered lesions, lesions clustered in small areas or large affected fields without reference to specific absolute numbers of lesions. Recognising that complete lesion clearance is rarely achieved in real-life practice and that AK is a chronic disease, the suggested treatment goals are to reduce the number of lesions, to achieve long-term disease control and to prevent disease progression to invasive squamous cell carcinoma. In the clinical setting, physicians should select AK treatments based on local availability, and the presentation and needs of their patients. The proposed AK treatment algorithm is easy-to-use and has high practical relevance for real-life, office-based dermatology. areas or large affected fields without reference to specific absolute numbers of lesions. Recognising that complete lesion clearance is rarely achieved in real-life practice and that AK is a chronic disease, the suggested treatment goals are to reduce the number of lesions, to achieve long-term disease control and to prevent disease progression to invasive squamous cell carcinoma. In the clinical setting, physicians should select AK treatments based on local availability, and the presentation and needs of their patients. The proposed AK treatment algorithm is easy-to-use and has high practical relevance for real-life, office-based dermatology.

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“…Three different studies show a complete resolution of 29% [15], 31% [16], and 47% [17], respectively. When AKASI was calculated for treated areas only, we found a median AKASI reduction of 42.9%, which might be equivalent.…”

Section: Discussionmentioning

confidence: 99%

Diclofenac Sodium 3% in Hyaluronic Acid 2.5% Gel Significantly Diminishes the Actinic Keratosis Area and Severity Index

Schmitz

Gupta

Segert

et al. 2018

Skin Pharmacol Physiol

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Background/Aims: Actinic keratosis area and severity index (AKASI) is a new assessment tool to quantify the severity of actinic damage on the head. Thus far, it has not been evaluated in monitoring the efficacy of field-directed topical treatments in actinic keratosis (AK) in routine clinical practice. Thus, the aim of this study was to determine treatment outcomes by using AKASI 3 months after the initiation of topical application of diclofenac sodium 3% in hyaluronic acid 2.5% gel (DFS) in patients with AKs on the head. Methods: We performed a retrospective analysis of patients with AKs who had AKASI scores prior to and after treatment with DFS. Results: Of the 24 patients included, 20 (83.3%) showed an improvement in AKASI, 2 (8.3%) a stable AKASI, and 2 (8.3%) a worsening of AKASI after a median (interquartile range) follow-up period of 91.5 days (89.8–104.3). The median AKASI reduction was 31.4% (16.7–59.1). The Wilcoxon test showed significant differences (p = 0.0008) between baseline and posttreatment AKASI values. Conclusions: AKASI is an easy-to-use quantitative tool for assessing the treatment outcome of field-directed therapies. Field-directed therapies of AK should no longer be monitored by assessments based on lesion counts alone.

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Topical diclofenac in hyaluronan gel for the treatment of solar keratoses

Cited by 85 publications

References 11 publications

Randomized, Double-Blind, Placebo-Controlled Phase IIB Trial of the Cyclooxygenase Inhibitor Ketorolac as an Oral Rinse in Oropharyngeal Leukoplakia

Randomized, Double-Blind, Placebo-Controlled Phase IIB Trial of the Cyclooxygenase Inhibitor Ketorolac as an Oral Rinse in Oropharyngeal Leukoplakia

Real-world approach to actinic keratosis management: practical treatment algorithm for office-based dermatology

Diclofenac Sodium 3% in Hyaluronic Acid 2.5% Gel Significantly Diminishes the Actinic Keratosis Area and Severity Index

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