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Binge Eating

Acne

Acne Clinical Research Study FAQ

What is the purpose of a clinical study?

Clinical studies (also called clinical trials) are used to learn
about the safety and effectiveness of new medications,
medical devices, and medical procedures. Although there
are many types of clinical trials, all must conform to strict
rules set by each country’s regulator authorities. These
rules help protect the rights and safety of those who
volunteer to take part in clinical trials.

What is the medication being evaluated in this study?

The study medication is called DMT310 and is applied to
the face once weekly for 12 weeks.

Will I have to pay for anything if I participate?

If you (or your child) choose to join the study, you will
receive all study-related care and medication at no cost.
Health insurance is not required to participate.

Will I be compensated if I participate?

Yes, you may be compensated for your travel to attend
each study visit. Your local study center will be able to
discuss these details with you.

Does everyone in the study receive DMT310?

No, as part of the study participants will be randomly
assigned (by chance) to use either:
– DMT310 (2 in 3 chance)
– A “placebo” (1 in 3 chance)
The placebo looks just like DMT301, but contains no
active ingredient. Neither you nor your doctor will know
whether you receive DMT310 or the placebo.
This is a common technique in clinical studies, as it
helps doctors and researchers better understand the
effects of the investigational medication without bias.

How long does the study last?

The study lasts about 3 to 4 months. During this time, you
(or you and your child) will meet with your study doctor up
to 6 times. These visits allow your study doctor to closely
monitor your acne, or that of your child, as well as discuss
your overall experiences.

What happens during the visits?

At every visit, you will be asked about how you (or your child)
are feeling, and your study doctor will examine your (or your child’s) skin. Your study team will also review with you how to apply the study medication. For 2 of the visits, you (or your child) will also receive a brief physical exam. In addition, at both the first and last visit you (or your child) will be asked to provide routine blood samples for safety tests.

Before you (or your child) decide to participate, your study team will provide you with a detailed summary of what will happen at each visit, so that you can make an informed decision about joining the study.

What if I join the study and decide I do not want to participate anymore?

As with all clinical studies, your participation is completely
voluntary. You or your child may leave the study at any time
without any effect on your future medical care.

How many people will participate in this study?

About 555 people are expected to participate in the study,
at approximately 20 – 30 centers throughout the US and
Latin America.

I am interested in possibly moving forward. What is the next step?

Please contact your local study center, and they will work
with you to schedule a convenient time for your initial visit.

Vitiligo

Hidradenitis Suppurativa

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Frequently Asked Questions

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