1. Sun damage causes wrinkles
Skin Wrinkles
Sun damage causes wrinkles

2. The Sun Wrinkled skin Skin proteins (Elastin, collagen) Protection
Treatment
Wrinkled skin
Students to fill in details of what they remember from their GCSE sciences (notably P2 B1, B2 and B5)
Skin proteins
(Elastin, collagen)

3. Skin proteins (Elastin, collagen)
The Sun
UV:
Large amounts kill cells
Small amounts damage a cell’s DNA (gene mutations)
UV radiation
EM radiation
Ionizing radiation
break particles into ions
free radicals are produced
Protection
Treatment
Wearing clothes and sunscreen to absorb the UV
Moisturise
Anti-oxidants
Specific skin creams and serums
Wrinkled skin
Staying out of the sun in the shade
ALARA – reduce the risk as low as reasonably acceptable
UV breaks down collagen and reduces synthesis of new collagen
Collagen and elastin are structural proteins
Proteins can be enzymes or structural proteins
Genes are the codes for the body to make proteins.
Skin proteins (Elastin, collagen)

4. Other external factors involved in skin wrinkling
Facial Expressions – lines develop as skin ages and loses its elasticity
Gravity – in your fifties elasticity declines dramatically – tip of nose droops, eyelids fall, jowls form
Sleeping position – over years sleep lines develop into wrinkles due to position of face on your pillow
Smoking- 10 years of smoking gives more deeply wrinkled and leathered skin than in non-smokers

5. Your genes also contribute to ageing
Genes control how quickly normal ageing occurs
Many different genes are involved
Genes for the structural proteins collagen, elastin fibrillin
Genes for enzymes that make collagen, elastin fibrillin
Genes for melanin – naturally browner skins age less rapidly
Genes for enzymes that repair DNA damage

6. Collagen and Elastin form fibres

7. If the amount of collagen fibres decreases then the skin begins to sag and be less plump. This causes wrinkles.

8. Design an experiment to test a new face cream
You have to decide:
Will you test it on people straight away?
What testing methods are normally used on new medicines?
A new cream that might have a better effect than previous creams or no cream should be tested first on skin cell cultures to see if it is safe and does not damage the cells. If it is believed to have some effect on the cells that can be measured then its effectiveness can be measured.
If it is safe (and effective perhaps) then it would be tested on animals – this tests whether it is safe in whole animals.
Only then should it be tested on volunteers. These people should give “informed consent” to be in a trial.

9. Design a good trial What age group will you test it on? Why?
Gender? Why?
Number of people. Explain your decision
Do you need a control group? If so what will you use on them? Explain your decision
How long will you test it for?
What will you measure?
How will you know if it is effective?
Only test on age groups concerned ie those that might have wrinkles so not under 35?
Gender might be important: could just try women (most likely customers) for consistency, but then will have no data for men and lose half your potential market!
As many people as possible to make the results reliable and minimise the effects of any anomalous results (outliers). With enough people then proper statistical tests can be done to see if any improvements found are significant. It also allows for the fact that some people may drop out of the trial. Have to balance the wish for large numbers with the cost of the trial.
There should be a group of similar people who are using a placebo or the old type of cream – this will allow you to be sure that any improvement that is detected must be due to the new cream. The two groups are randomised – this makes the testing fair.
Quite a long time – probably 6 months – year.
Length, Depth or number of wrinkles. Amount of important proteins in skin samples (skin biopsy – not on the face!)
Does the new test cream reduce the amount of wrinkles in the skin, and increase the amount of key skin structural proteins?

10. Improve your trial How should you choose the people?
Are there any confounding variables that can be controlled?
Who should conduct the experimental trial?
Should the people in the trial know if they are getting the test cream or a placebo?
Should the assessors know who had the test cream?
Randomly – but avoiding any who are unwell.
You cannot control genetic and environmental differences easily in human studies so making the two groups of people a similar mix of types should reduce the impact of confounding variables. The method of applying the cream should be made into a standard procedure to be followed by all participants.
Impartial, non-biased experts – dermatologists. Even if the research is paid for by the company who make the cream the scientists should be free to publish any real differences they find whichever way the results of tests turn out.
The best test would be a double blind trial where neither the scientist of the participants in the study know which group they are in.

11. Reliable and Accurate? How could the results be made more reliable?
Could your study be made more accurate?
How could you get the public to believe your results?
Larger numbers of participants would make the result more reliable.
A more precise method of applying the cream or of measuring the result would improve the accuracy.
Getting the results published in a trusted scientific journal after peer-review will make the conclusion more acceptable because they will have evaluated the experiment and the results. This will also allow other scientists to do further tests to back up the results.

12. Another way to test?
Would it be sensible to test the two different creams on different sides of one person’s face?
Give reasons for and against:
For:
The genetic and environmental background of each individual would be the same.
The same skin type and previous damage.
Against:
The individual might mix up the creams and make the test invalid.
There might be large differences in the effectiveness of the creams which would not be helpful to the individual.

13. A different study on anti-ageing cream
In a double-blind study, a topical vitamin C complex was applied to one half of the face and a placebo gel to the opposite side. Clinical evaluation of wrinkling, pigmentation, inflammation, and hydration was performed prior to the study at weeks 4, 8, and 12. The results showed a statistically significant improvement of the vitamin C-treated side, with decreased photoaging scores of the cheeks and the perioral area. The peri-orbital area improved in both the vitamin C and placebo-gel group, probably indicating improved hydration. The overall facial improvement of the vitamin C side was statistically significant. Biopsies showed increased collagen formation in the vitamin C group. This study showed that topically applied vitamin C results in clinically visible and statistically significant improvement in wrinkling when used for 12 weeks. This clinical improvement correlated with biopsy evidence of new collagen formation (Fitzpatrick et al. 2002).In response, cosmetic companies have increased the percentages of active ingredients with the goal of replicating the antiaging effects revealed in the published studies.
The problem of increasing the level of active ingredients is that the wrong layers of the skin can be overly saturated resulting in irritation and reduced efficacy.
The first step in resolving this problem is to encase the active ingredients so that they can be absorbed through the top layer into the lower layers of the skin where they are most active. The second step is to design a delayed release system so that the active ingredients can be released over an extended amount of time.

14. Give out the prerelease papers for Biology.

15. “Public understanding of Science” in the media and advertising
Anti-wrinkle cream
“Public understanding of Science” in the media and advertising
Biology B7 Pre-Release 2011

16. The public respond to the media reporting science.

17. …………………………………………………………............…. 2. What is a scientific study?
1. Scientists thought that the new cream was an improvement on other anti-wrinkle cream. What was their evidence?
………………………………………………………… ….
2. What is a scientific study?
………………………………………………………………….….
3. The results were published in a medical journal. What does this suggest?
…………………………………………………………………….....
4. How much better is the new cream than other creams – as a percentage?
…………………………………………………………………………
A study found people who used the cream for a year had fewer wrinkles. The wrinkles were also smaller.
A study where an investigation is carried out, controlling other factors to make the test fair and accurate and where the conclusion is based on sufficient results so that it is reliable.
The results of the study will have been peer-reviewed before being published in a Medical Journal.
100% . This is the same as “twice as good”.

19. …………………………………………………………............….
5. The ingredients in the cream increased the production of fibrillin in the skin. Suggest what type of protein fibrillin is?
………………………………………………………… ….
6. Why did the cream not just contain fibrillin?
………………………………………………………………….….
7. The lupin extract increases the production of the protein fibrillin. Suggest how this might happen.
…………………………………………………………………….....
8. What unexpected side effects might occur?
…………………………………………………………………………
A structural protein like elastin. (Or perhaps an enzyme that allows more protein synthesis of elastin or reduces break down of elastin)
Fibrillin is a protein so it is too large to enter a cell across a cell membrane. Skin needs human fibrillin and this cannot be made from plant extracts or from genetically modified organisms.
Fibrillin is a glycoprotein that is transported out of cells into the extracellular matrix becoming part of elastic fibres.
The extract might switch on inactive genes on in the skin cells. Or it might inhibit the breakdown of fibrillin.
Other genes might also start to produce other proteins at higher levels.

20. 9. Why is it important that the research was unbiased?
……………………………………………………………………..
10. Was the research conducted in an unbiased manner?
………………………………………………………… ….
11. How could the professor show that his research was unbiased?
………………………………………………………………….….
12. Can you conclude that the cream is effective?
…………………………………………………………………….....
13. What role did the media play in the promotion of this cream?
…………………………………………………………………………
Bias might give unfair results or conclusions.
Maybe not: - The professor was funded by the manufacturer. He might get further funding if he published the “right results” that the manufacturer wanted
Probably: - He designed the tests independently.
He could get agreement to publish his findings whichever result he found.
He used the same methods approved for testing new medicines
Yes - The cream was effective in most people (70% of people).
No – The cream was not effective in 30% of people.
The manufacturer advertised the good results of the scientific study to the public.

21. ……………………………………………………………………..
14. What evidence is there that these claims are not just false claims?
……………………………………………………………………..
15. Would the cream only remove 70% of Wendy’s wrinkles?
………………………………………………………… ….
16. Would Sue get even better results by using twice as much?
………………………………………………………………….….
The claims are based on independent research using correct scientific procedures. The trial should have been randomised and double blind but we are not given this information.
No ,this means that there is a 30% chance it would not work, but a 70% chance it would work.
This has not been tested so there is no evidence to support this idea. There may be risks involved in using too much.

22. ……………………………………………………………………..
17. The new cream is twice as good as normal anti-wrinkle creams but the new cream was found to be effective in 70% of the people who tested it. What does this tell you about the effectiveness of normal anti-wrinkle creams?
……………………………………………………………………..
18. Is the method of measuring the effectiveness of the new cream accurate?
………………………………………………………… ….
Normal anti-wrinkle creams are only half as effective as the new cream so they must be effective in 35% of the people who used it.
There is no information given. Asking the individuals their opinion is subjective and non-quantitative so less accurate. Using trained dermatologists to make judgements and take measurements would make the results more accurate.

23. Further Information
See next slides and BBC news 2009 pdf

24. Funding of this research.
Professor was ‘independent’ but research was funded by company (Boots’)
Is this true independence?
The results would have been published either way.
Is he more likely to report something favourable to company sales because this might get him more work?
Why is it important to be independent?
To reduce the risk of bias that might give unfair results or conclusions.

25. How are new medicines tested?
1. On human cells
2. On animals
3. On human volunteers
A test group and a control group (having a placebo).
Blind test or double blind test (neither patient nor member of the research team knew who had which cream)
Both groups should be chosen randomly and of the same type of people eg those with sun damage aged 45-80
Large sample size is needed for results to be reliable.
The results can be tested for statistical significance.

26. What measurements were done?
Fibrillin levels test
Test each individual before starting the trial for base levels of fibrillin
Test again at end. (Skin biopsy from wrist)
Wrinkles test
Advanced clinical assessments by dermatologists comparing before and after.

27. How are results published?
Researcher checks the experimental design and the results.
Submits his paper to a scientific journal.
Independent scientists have to “peer review’ the work – they critically evaluate the study.
The Paper gets accepted and is published in the British Dermatological Journal
Other scientists repeat the research to see if the same results are found, or do related work to see if other results support the findings of the first study.

28. Testing active ingredients
How could you test which ingredient increased the production of fibrillin in the skin?
Test each active ingredient on tissue culture cells with a negative control (some neutral carrier with not active ingredient)
Test each ingredient in an aqueous cream on individuals and compare to others with aqueous cream but no active ingredient.
Combinations of ingredients may have to be tested.