Help us identify which outcomes to measure in acne clinical trials
List of items
- Physical signs of acne assessed by a healthcare practitioner
Physical signs are the visible features of acne such as spots, redness, pus, skin texture and skin greasiness. They also include the extent of the acne (areas of face and/or body involved). They can be measured by a healthcare practitioner or by the patient (see next item).
- Physical signs and symptoms of acne assessed by patients
Physical signs are the visible features of acne such as spots, redness and greasy skin. Symptoms are features of acne which doctors cannot see or feel so cannot assess. They include things like soreness and pain or itchiness. They do not include side effects of topical acne treatments.
- Global acne severity assessed by a healthcare practitioner
To assess global acne severity, a practitioner would take a careful look at a patient’s skin and might also run his/her fingers across it. He or she would then decide how bad the acne is on a scale of say 0 to 10 where 10 is very bad acne and 0 is clear skin. It’s exactly the same as the patient would do but the doctor won’t know how bad it was yesterday or last week whereas the patient will.
- Global improvement in acne assessed by the patient
To assess global improvement, a scale is used. A typical one would have five points on it where 0 = worse, 1 = no change, 2 = slight improvement, 3 = moderate improvement and 4 = excellent improvement. Participants would be asked at the end of trial how much improvement they thought the treatment had produced.
- Global improvement in acne assessed by a health-care practitioner
To assess global improvement, a scale is used. A typical one would have five points on it where 0 = worse, 1 = no change, 2 = slight improvement, 3 = moderate improvement and 4 = excellent improvement. Practitioners would decide at the end of trial how much improvement they thought the treatment had produced.
- Satisfaction with appearance
When someone with acne looks in the mirror, how do they react to their appearance? Does the reaction reflect how they feel about their skin? If their acne is improving, are they happier about their appearance? In a trial, we’d measure how satisfied someone was with their appearance at the start and at the end. We’d probably use something like a scale of 0 to 10 where 0 was completely dissatisfied and 10 was completely satisfied. An alternative might be to use a body image questionnaire.
- Satisfaction with acne treatment received
For every treatment, there is a balance between benefits and harms. This balance tends to influence how well people regard a treatment. Other things which might affect satisfaction are: how easy it is to use/take, how long it takes to work (see item 10), whether it has any side effects. At the end of a trial, people might be asked how satisfied the were with the treatment they received and asked to give it a score on a scale of 0 to 10 where 0 means completely dissatisfied and 10 means completely satisfied.
- Self-esteem and self-confidence
Having acne can alter how someone feels about themself and how they evaluate their own worth. It can affect confidence and self-respect. In a trial, we’d use something like a short questionnaire to measure different aspects of self-esteem at the start and again at the end.
- Health-related quality of life
Health-related quality of life is a broad concept that includes self-reported physical and mental aspects of health. Some of the other items on the list are specific aspects of health-related quality of life, for example, self-esteem and also self-assessed symptoms and signs. Rather than having specific questionnaires about each one, they can be combined into a longer questionnaire which might have several parts. All the items within each part are linked together and have to be interpreted together.
- Speed of improvement in acne
If treatments take a long time to work, people can get fed up using them. In a trial, we might measure speed of improvement by asking people to come in several times during the study or we could simply ask people when the first noticed their skin was looking or feeling better.
- Long-term control of acne (stopping recurrences)
Often the last visit of a clinical trial is at the end of treatment. Many people with acne will know from experience that the effects of treatment can wear off and the acne can come back, sometimes slowly, sometimes quite quickly. In a trial, we can examine long-term control by asking people to come back weeks or months after the treatment period has ended to see of the acne has returned and, if so, how badly.
- Long-term consequences of acne treatment received
Because acne has a tendency to come back if treatment is stopped, it is often necessary to keep using it for long periods or to have to start using it again. This makes people worry that it might have negative long-term consequences for their health. This is difficult to measure in a clinical trial as it requires a long period of follow up. There are other ways of finding out.
- Absence of acne flares
People with acne often notice that is gets worse at certain times, and they sometimes think they know what has caused it to flare up. In women, acne can flare before a period. Many people think certain foods and stress can cause flares. In a trial, it would be difficult to assess flares as they may not happen when an assessment is due but patients could be asked to record flares in a diary.
- Value of acne treatment to patient
All types of acne treatment have costs for both the provider and for the patient. In a trial, we could ask patients whether they thought the treatment they had received was value for money. There are various ways of doing this and some of them can be done by people who don’t have to pay a prescription charge.
- Extent of scars and dark marks
Although scars and dark marks are common features of acne, they tend to last longer than active spots and don’t respond as well to many conventional acne medications. People also worry about spots leaving scars or dark marks as they heal and still having these when active acne had stopped. Therefore, it might be better to assess scars and dark marks separately from other types of acne spot.
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