Document Detail

Topical diclofenac: new preparation. Moderate efficacy in actinic keratosis.
MedLine Citation:
PMID:  15532138     Owner:  HSR     Status:  MEDLINE    
(1) Many treatments are available for actinic keratosis. The most widely used is cryotherapy. Topical application of 5% fluorouracil cream is a second-line option. (2) Marketing authorisation has been granted for a topical gel containing 3% diclofenac, a nonsteroidal antiinflammatory drug. The excipients include 2.5% hyaluronic acid. (3) Animal pharmacology studies and in vitro tests show that hyaluronic acid delays the transcutaneous uptake of diclofenac, leading to higher concentrations in the epidermis. (4) No comparative trials with fluorouracil or other drugs have been published. Five trials comparing 3% diclofenac topical gel with its excipient are available. They show that it takes at least two or three months of treatment for the lesions to disappear in one-third to one-half of patients. Indirect comparison suggests that diclofenac is less effective than fluorouracil in terms of lesion disappearance one month after the end of treatment. The subsequent risk of relapse is unknown. (5) Local adverse effects are numerous and frequent, and include contact dermatitis, skin rash, dry skin, desquamation, pruritus, local pain, and paresthesia. Adverse effects can be due to either diclofenac or to the excipient, and seem to be less intense than with topical fluorouracil. (6) Trials have shown that topical diclofenac is effective at a dose of 0.5 g of gel applied twice a day, but this precise dose is unlikely to be used as no measuring device is included in the packaging. (7) In practice, diclofenac topical gel is less effective than fluorouracil, and is only a moderately effective option when fluorouracil is poorly tolerated and when physical treatments such as cryotherapy fail.
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Prescrire international     Volume:  13     ISSN:  1167-7422     ISO Abbreviation:  Prescrire Int     Publication Date:  2004 Aug 
Date Detail:
Created Date:  2004-11-08     Completed Date:  2004-11-24     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9439295     Medline TA:  Prescrire Int     Country:  France    
Other Details:
Languages:  eng     Pagination:  138-9     Citation Subset:  T    
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MeSH Terms
Administration, Cutaneous
Administration, Topical
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use*
Dermatologic Agents / administration & dosage,  adverse effects,  therapeutic use*
Diclofenac / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use*
Double-Blind Method
Drug Combinations
Hyaluronic Acid / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use
Porokeratosis / diagnosis,  drug therapy*
Treatment Outcome
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Dermatologic Agents; 0/Drug Combinations; 0/Gels; 15307-86-5/Diclofenac; 51-21-8/Fluorouracil; 9004-61-9/Hyaluronic Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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