Behind the Headlines

Thursday June 18 2009

Researchers claim that “a cream used to treat early signs of skin cancer can erase wrinkles and make skin look younger,” the Daily Mail reported. It said that the cream, used to treat a form of pre-cancer called actinic keratoses, could also reverse signs of ageing.

The cream was tested on 21 healthy people between the ages of 56 and 85. All of them experienced irritation with red, scaly skin at the beginning of the treatment, but after ten weeks they rated their skin as improved. This result was also confirmed through clinical assessment.

The researchers say that many people would find the cream’s side effects unacceptable if used for cosmetic purposes. As the Daily Mail said, the volunteers’ skin looked like “raw hamburger meat” during therapy. The researchers say that the cream’s restorative effects may be seen as an additional benefit for people with actinic keratoses and could give them extra motivation to undergo the treatment.

Where did the story come from?

This research was carried out by Dr Dana L Sachs and colleagues from dermatology departments at the University of Michigan and Johns Hopkins University. The study was supported by Valeant Pharmaceuticals International, the maker of the cream being studied. The study was published in the peer-reviewed medical journal Archives of Dermatology.

What kind of scientific study was this?

The study investigated what effects a course of skin cream for treating actinic keratoses would have on the wrinkles, texture and pigmentation of the skin. Actinic keratoses (also known as solar keratosis) are thick, scaly or crusty patches on the skin that are caused by exposure to sunlight. They are most common in fair-skinned people and those who have been frequently exposed to the sun. While they are usually harmless, actinic keratoses sometimes develop into a type of skin cancer called squamous cell carcinoma.

The cream investigated by this study contains the chemical fluorouracil, which is usually used to treat cancers of the colon, head and neck, pancreas and other organs. Since 1963, it has been used in creams to treat actinic keratoses.

In this case series, the researchers enrolled 13 men and eight women in a 24-week study. All the volunteers were between 56 and 85 years of age with moderate to severe sun damage and actinic keratoses on the face. The volunteers needed to be in general good health and willing to have skin biopsies taken from the face. They could not be pregnant, breast-feeding or have a history of allergy to any ingredients of the cream.

All volunteers were given the same 5% cream to be applied to the whole of the face twice a day to for two weeks. The study was an open-label study with no control group for comparison. All participants knew they were getting the active cream.

The researchers measured the cream’s effects with before-and-after photos of the volunteers’ faces, close-up photos of any actinic keratoses, and 3mm punch biopsy specimens of sun-damaged skin from behind the ears and forehead. The biopsies were repeated at two weeks (24 hours after the last cream was applied), four weeks, 10 weeks and 24 weeks. Various molecular markers of inflammation and protein levels in the skin were estimated from the tissue samples.

The volunteers’ skin was clinically assessed at the same intervals using scores for a global assessment of overall photoageing severity, coarse wrinkling, fine wrinkling, dark spots, mottled hyperpigmentation, sallowness and tactile roughness. The researchers counted the actinic keratoses at the beginning of the study and at subsequent visits. They asked the volunteers to complete a questionnaire at 10 weeks.

What were the results of the study?

The researchers reported that the day after the final fluorouracil treatment was applied, there were significant increases in the molecular markers of inflammation and cellular damage. At week four, there was evidence of increases in the production of procollagen (a forerunner to collagen).

Actinic keratoses and photoaging were improved and this was statistically significant. Most patients rated photoaging as improved and said they would be willing to have the therapy again.

What interpretations did the researchers draw from these results?

The researchers say that the fluorouracil cream applied to the face causes skin injury, which leads to healing and then skin remodelling, resulting in improved appearance. They suggest that this mechanism is “reminiscent of that seen with laser treatment of photoageing”.

What does the NHS Knowledge Service make of this study?

This study has shown that some molecular changes attributed to this cream are linked to a sequence of events that results in improved skin appearance. Although the subjective improvements in appearance have been observed by people using this cream before, this study has clarified how these improvements occurs. There are some notes of caution:

  • The clearance of sun damage spots was predictable and the cream is licensed for this purpose. Its application to skin that has only wrinkles and no sun damage is not currently a licensed use.
  • After two weeks of applying the cream, the average number of actinic keratoses had significantly increased from 11.6 to 59.5 per patient. This may be the result of miscounting, as the researchers suggest, but it also suggests that this cream makes the condition worse before it gets better. The degree of reddening and scaliness of the skin at two weeks was substantial.
  • There are good reasons why researchers and volunteers would have realised they were getting an inert control cream, if one had been used. For example, their skin would not have gone red or flaky with the inert cream. However, it is still important that a control group is used where possible. Without one, it is not possible to say if this cream is any better than other creams or laser treatment.
  • Long-term results, safety or side effects were not reported by the researchers.

Overall, this small study improves our understanding of the repair mechanisms in sun-damaged skin in people over 50. The results do not suggest that the cream should be routinely used for cosmetic purposes as its side effects are considerable. The researchers say that the cream’s restorative effects may be seen by people with actinic keratoses as an additional benefit and give them extra motivation to undergo the treatment. They also say that while the cream may be cheaper than laser treatment, many people would not think that the cream’s side effects and length of treatment were acceptable, and it may not achieve the same degree of improvement as laser treatment.

Analysis by Bazian

Edited by NHS Choices

Links to the headlines

Anti-cancer cream fights wrinkles. BBC News, June 16 2009

The cancer cream 'that gets rid of sun wrinkles'. Daily Mail, June 15 2009

Links to the science

Sachs DL, Kang S, Hammerberg C et alTopical Fluorouracil for Actinic Keratoses and Photoaging. Arch Dermatol 2009; 145: 659-666

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