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March 5, 2021 Clinical Trials

NEW study for ages 9 years and older. 3-week oral antibiotic study for back and/or chest acne. At least 20 lesions are required. Photographs will be taken.

How can you participate?

Inquire about how you can participate in this study today.

TO LEARN MORE ABOUT THE ACNE STUDY, CONTACT:
studies@acderm.com or call 817-795-7546 ext. 339


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March 5, 2021 Clinical Trials

NEW study for adults 18 years and older with a diagnosis of psoriasis. Must have history of at least 6 months on Consyntex or Talz. No prior use of Skyrizi. No investigational drug use within 30 days. No major surgeries within 12 weeks, or major planned surgeries. You are being asked whether you would like to voluntarily participate in a research study of a drug called risankizumab (SkyriziTM).

This research study involves the use of an approved drug called risankizumab (SkyriziTM) to treat moderate to severe psoriasis. This study is being run in approximately 50 research centers in 9 countries and is expected to enroll approximately 250 subjects.

If you decide to participate, you will be in this study for up to 64 weeks. The study comprises 3 periods: There will be a 30-day Screening Period, a 52-week open-label study period and a 20-week follow-up period following the last dose of study drug scheduled at Week 40 visit (weeks 40-52 of the open-label period will also be weeks 1-12 of the follow-up period). The open-label period means that you, your study doctor and AbbVie know that what study treatment you are receiving.

You may need to come in for additional (unscheduled) visits if necessary, as determined by your study doctor. If you are eligible to receive study treatment, you will receive 2 injections of active risankizumab 75 mg (150 mg total dosage) subcutaneously (SC) at Weeks 0 and 4 visits, and then every 12 weeks (q12w) until the last dose at Week 40 visit. At any time, you may choose to discontinue from the study and end study participation early, or your study doctor may discontinue your participation for any reason at any time.

AbbVie is sponsoring this study. Being in this study does not replace your regular medical care. AbbVie may stop this study prematurely, either in its entirety or at any study site, for reasonable cause, provided that written notice is submitted in advance of the intended study stop.


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March 5, 2021 Clinical Trials

Arlington Research Center is looking for children and adults, aged 6 years and up who have eczema, to participate in a clinical research study evaluating an investigational cream. This study includes up to 5 visits for 2 months.

Studies for youth and adults. Must have a history of atopic for at least 3 months for youth 6-17 years of age, and for at least 6 months for adults 18 years and older. Study patients previously on the ARQ-151 are excluded.

How can you participate?

Inquire about how you can participate in this study today.

TO LEARN MORE ABOUT THE INTEGUMENT STUDY, CONTACT:
studies@acderm.com or call 817-795-7546 ext. 339


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March 5, 2021 Clinical Trials

NEW study for adults 18 and older. Topical cream and at-home phototherapy system. Must have facial vitiligo. Subjects with vitiligo on the hands, forearms, or elbows may treat areas in addition to the face with the cream. Begins in mid-March.

How can you participate?

Inquire about how you can participate in this study today.

TO LEARN MORE ABOUT THE VITILIGO STUDY, CONTACT:
studies@acderm.com or call 817-795-7546 ext. 339


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December 30, 2020 Clinical Trials

If your child has severe eczema, learn how he or she could participate in this research study of an oral study drug for children 6 months to 11 years of age.

The purpose of this study is to examine how the body processes the study drug, evaluate drug safety and assess how the safety and taste hold up (tolerability and palatability) in children (6 months to 11 years old) with severe atopic dermatitis, also known as eczema. The study medication comes in a tablet form or a solution that will be taken by mouth.

WHO MAY PARTICIPATE IN THIS STUDY?
Your child may qualify for this research study, if the following applies to your child:

  • Your child is between 6 months to 11 years old
  • Your child has severe Atopic Dermatitis
  • Your child is experiencing active Atopic Dermatitis symptoms, such as: itchiness, irritated dry skin, redness, etc.

You may receive reimbursement for your time and travel expenses related to study participation.
Please visit http://www.clinicaltrialsandme.com/M16-049 for locations participating in the study.


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December 30, 2020 Clinical Trials

While severe psoriasis affects the skin, causing it to itch and burn, it can also have an emotional impact on adolescents, as well as their parents.

Because of the raised, red, scaly patches on their skin, many adolescents feel ashamed or embarrassed by their condition. These emotions can cause them to not want to hang out with friends, attend school functions, or participate in extracurricular activities.

For parents watching these physical and emotional effects, it’s difficult when other treatments have not been successful in managing their child’s psoriasis.

Because many adolescents and their families struggle with psoriasis, this research study is being conducted to evaluate an investigational drug for severe psoriasis. In this study, researchers want to learn more about the safety and effectiveness of the investigational drug.

The investigational drug has not been approved by any regulatory agency for the treatment of children and adolescents with this condition. It is only available to children and adolescents in research studies like this one.

The results of this study will provide more information about the investigational drug and whether it could one day be approved for children and adolescents with severe plaque psoriasis.

What will happen during this study?

To participate in this study, all patients will go through a screening process to determine if they are eligible. If a patient meets the study requirements, agrees to participation, and has their parents’ permission, they will begin the study.

Patients will receive five subcutaneous injections (needle inserted just beneath the skin) of the investigational drug over the course of 40 weeks. All injections will be given at the study clinic.

Total participation in this study will last up to 65 weeks, which includes approximately 9 study clinic visits for injections of the investigational drug, blood tests, and other assessments, as well as 1 follow-up phone call. Patients who complete participation in this study may be able to take part in a 52-week extension study in which all patients will continue receiving the investigational drug.

What are the benefits and risks related to this study?

It’s possible patients could benefit from study participation, but that is not guaranteed. However, participation in this study may benefit children and adolescents with plaque psoriasis in the future.

Patients could also experience one or more side effects. Before beginning the study, the study staff will review all study-related risks and side effects with parents and patients.

Throughout their study participation, patients will be monitored closely. The sponsor of this study was required to design a protocol, which explains all study procedures. An independent review board responsible for patient safety reviewed this protocol, approved it, and requires that
it be followed exactly as written.

Who is eligible to participate in this study?
To be eligible for this study, patients must:

  • Be 12 to 17 years of age
  • Have been diagnosed with chronic plaque psoriasis for at least 6 months

All study-related visits, tests, and drugs will be provided at no cost. In addition, compensation for study-related travel may be provided.


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December 30, 2020 Clinical Trials

We know life with Hidradenitis Suppurativa isn’t always easy.

There are many unanswered questions surrounding the causes of HS and the painful and distressing symptoms it triggers in the body. With limited approved medical treatment options available, it’s important to keep looking for potential answers.

For this reason, the Ivy Clinical Research Study is investigating 3 different possible treatment options to assess the benefits each could offer to people with moderate to severe HS.

The Ivy Study may be an option for you if:*

  • you have a diagnosis of moderate to severe HS
  • you are 18 – 75 years of age
  • you have HS lesions in two different locations on your body

*There are other requirements for participation in the study. The study doctor will be able to explain these to you.


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July 29, 2020 Clinical Trials

Youth ages 12-18 years old may qualify for this new Chronic Plaque Psoriasis study.

Study focuses on how a drug called Risankizumab may help children with moderate to severe psoriasis. Psoriasis is a condition in which skin cells build up and form red, itchy, scaly patches. Risankizumab is approved for use in adults however, it has been not been approved for children in the United States and other countries, and we want to learn more about how it works. This is called a “research study.” This is the first study where the study drug will be tested in children.

If you decide to be in the research study, you will be asked to take part in this study for about 65 weeks and this may include 9 study visits and 1 follow-up phone call. You will receive a risankizumab injection every 12 weeks after the week 4 visit.

You will need your parent’s approval to participate in this study if you are younger than 18.

Call 817-795-7546 or email studies@acderm.com if you think you would like to participate in this study.


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July 29, 2020 Clinical Trials

Open to adolescents only. Patient must have moderate Atopic Dermatitis to be eligible to participate. Must meet the following criteria to participate:

Aged 12-18 years old

Active moderate to severe AD on body surface area (BSA) of ≥10%, and pruritus
Candidate for systemic therapy or have recently required systemic therapy for AD
No prior exposure to any JAK inhibitor
Able and willing to discontinue current AD treatments prior to the study
No requirement of prohibited medications during the study
No other active skin diseases or skin infections requiring systemic treatment that would interfere with appropriate assessment of AD lesions
Female subjects cannot be pregnant, breastfeeding, or considering pregnancy during the study.

The study is expected to last for just under 3 years.

Call 817-795-7546 or email studies@acderm.com if you think you would like to participate in this study.


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July 29, 2020 Clinical Trials

Adults 18-75 years old may qualify for this 12-week (or potentially longer) study. 6 months of clinical diagnosis is required. This study is for patients that have a skin condition known as Plaque Psoriasis (“Psoriasis”).

The purpose of this study is to understand how well tapinarof 1% cream works in treating your Psoriasis and to get more information about tapinarof 1% cream’s safety. In this study about 500 people in the United States and Canada will be taking part. Tapinarof is an investigational cream.

There will be 2 (two) groups in the study. One group will get the tapinarof 1% cream, the other group will get the vehicle cream. A computer will put you as a study participant to one of the groups by chance (like a roll of the dice). Neither you nor the study doctor can choose a group. You have a 66.6% chance of being placed in the tapinarof 1% cream group and a 33.3% chance of being placed in the vehicle cream group.

After the screening study visits, if you qualify to take part in the study, you will be scheduled to see the study doctor at their office on Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12, and Week 16. You might have to visit the study doctor at other times (unscheduled visits) if your Psoriasis gets worse. During the visits, you will have tests, and answer questions about any changes to your health.

At the Week 12 visit, if you qualify, you can choose to take part in a longer study (long-term) that lasts 40 weeks (about 9 months). All participants in the long-term study will use tapinarof 1% cream (open-label). You will have to sign an Informed Consent Form to participate in the open-label long-term study.

Call 817-795-7546 or email studies@acderm.com if you think you would like to participate in this study.


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