ALPHA – More Information

Welcome to the ALPHA More Information page, where you will find helpful information on the ALPHA trial by clicking on the links below:

What will happen to me if I take part?

Click each row for more information.

1. Screening visit – To make sure it is safe for you to take part

To make sure you are suitable to take part, you will have some screening tests done:

  • A blood sample
  • Details of your medical history and current medications
  • Examination of your hands
  • Women capable of having children will be asked to use a reliable form of effective contraception and follow a strict pregnancy prevention program (see participant information sheet for further details)

If the blood test shows that it is not suitable or safe for you to take part in this study, your doctor will discuss other treatment options with you.

2. Baseline visit

  • Examination of your hands
  • Blood sample
  • Urine pregnancy test for women capable of having children
  • Complete questionnaires about your hands and your health in general
  • You will be randomised to either receive Alitretinoin or PUVA therapy. This is decided at random by a special computer
  • Complete a medication diary

3. Treatment visits (interventional phase)

  • If randomised to Alitretinoin, you will need to take the tablets once a day with the main meal as instructed by your study doctor for 12 weeks
  • If randomised to PUVA you will attend the phototherapy clinic twice weekly for PUVA treatment for 12 weeks
  • Questionnaires and examination of your hands every 4 weeks

Depending on how your hand eczema is responding to either treatment, you may be asked to continue treatment for up to a further 12 weeks.

4. Follow up visits (follow up phase)

  • Questionnaires and examination of your hands every 4 weeks until week 36, then once every 8 weeks until you have been in the study for a total of 52 weeks (1 year)

5. What if the treatment doesn’t help?

If, after the first 12 or 24 weeks, your randomised treatment is not helping your condition, then your doctor will stop this treatment and treat you according to local standard practice.

6. Trial visits summary

Here is a summary of the visits that you will need to attend whilst on the trial:

Interested in taking part?

If you would like to find out whether you may be suitable take part in the ALPHA trial, please click on the self-screening questionnaire button.

There is also a list of hospitals that are currently taking part in the trial. Please keep checking this link as new hospitals will be added regularly.

 

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