The Department of Dermatology is currently involved in several clinical trials and registry studies. If you are interested in participating or learning more about any of the following studies, please contact us via phone, email, or the contact form below. All studies are available at no cost to the patient, and participants are paid a stipend for their time.
Active Studies
Atopic dermatitis – systemic treatment
We are looking for patients 18 years and older with moderate to severe atopic dermatitis present for 1 year or longer with at least 10% body coverage for a phase 2 study for the treatment of autoimmune and inflammatory diseases through an investigational IRAK4 degrader injectable medication. Participants need to have a history of inadequate response to topical steroid, or other systemic medications. Participants must not have a history of solid organ or stem cell transplant or use certain topical/systemic treatment in certain time limits (such as biologic therapies within 12 weeks, topical ruxolitinib within 4 weeks, etc.) to be eligible for the study.
Atopic dermatitis – systemic treatment
We are looking for patients 18 years and older with moderate to severe atopic dermatitis present for 1 year or longer with at least 10% body coverage for a two-part study to evaluate an experimental monoclonal antibody injection that targets inflammation. Part A of the study is to determine efficacy and Part B is to evaluate the effectiveness of the three different doses of the injectable. Participants need to have a history of inadequate response from topical and/or systemic medications prior to enrollment in the study. Participants must not have prior exposure to IL-13 mAbs or anti-IL- 13Rα1 in the past, must not have prior treatment with systematic non-biologic or phototherapy treatment within 4 weeks, and must not have prior treatment with other mAbs with the Th2 pathways, to be eligible for the study.
Atopic dermatitis – sleep disturbance
We are looking for patients 18 years and older with sleep disturbance from atopic dermatitis for a phase 4 study with a topical JAK1 and JAK2 medication that is currently FDA approved for atopic dermatitis. Participants need to have at least a 2-year history of atopic dermatitis, with pruritus/itching for at least 3 months, have body surface affecting being between 3-20%, NRS itch score greater than 4, sleeping less than 6.5 hours nightly, and not be working nighttime shifts. All participants will receive the study medication.
Atopic Dermatitis – registry
We are looking for patients 18 years and older with a diagnosis of atopic dermatitis who are currently on or about to start taking a medication or systemic biologic treatment for atopic dermatitis. Registry studies do not provide any medications, but they do help us better understand the psoriasis disease process and various treatments.
Plaque Psoriasis – systemic treatment
We are looking for patients 18 and older that have been diagnosed with plaque psoriasis for 6 months or longer prior to the screening visit that have over 10% Body surface area, PASI score greater than 12% and IGA more than 3%, for a study to evaluate the effect of Bimekizumab systemic treatment, a selective IL 17 inhibitor, on gene expression biomarkers with moderate to severe plaque psoriasis. Participants must be a candidate for phototherapy or systemic treatment for psoriasis and females may not be pregnant. Participants must have plaque psoriasis and not non-plaque psoriasis such as guttate or pustular, must not have any current or prior malignances prior to five years of screening (excluding NMSC), and selective medication/biologic usage (for example antibodies to IL-17 or TNF inhibitors within 3 months, etc.) to be eligible for the study.
Psoriasis – scalp involvement
We are looking for patients 18 years and older with psoriasis involving the scalp for at least 6 months or longer, with at least 3% of body involvement, who have failed at least one topical treatment in the past to participate in the study. This Phase 3 study will be investigating the efficacy and safety of an oral medication currently FDA-approved for moderate-to-severe plaque psoriasis. Participants must have plaque psoriasis to enroll in study, must not require active systemic treatment (other than NSAIDs) for autoimmune-related disease, must not have any current or previous malignancies in the last 5 years (excluding NMSC) and must not have exposure to certain biologics/medications (for example antibodies to IL-12/-23, or -IL-23 or Rituximab within 6 months of study, etc.) to be eligible for the study.
Psoriasis – pediatric
We are looking for patients 6 to 17 years old with a diagnosis of moderate to severe plaque psoriasis for at least three months with it covering at least 10% of the body surface with a PASI score of 12 or 10 with involvement in selective areas of the body such as scalp, genital ,axilla, or palms/soles, for a study with a biologic medication currently FDA approved for treatment of moderate to severe psoriasis in adults. Participant may not participate if they have had prior exposure to more than two biologic therapies, have a history of chronic alcohol or drug abuse, had a primarily failure to an anti-TNF agent, have guttate without plaque PSO, or have a hypersensitivity to any excipients of CZP or adverse event to PEG.
Psoriasis – non-pustular palmoplantar and genital
We are looking for patients 18 years and older with moderate to severe plaque psoriasis which include the palms and/or soles OR genital area for at least 6 months for a phase 4 study with an FDA approved oral TYK2 inhibitor to evaluate the efficacy and safety in participants with non-pustular palmoplantar and genital psoriasis. Participant must have PGA score more than 3, have failed at least 1 topical therapy and is a candidate for phototherapy or systemic treatment for psoriasis. Participants must not have major surgery within 8 weeks of the first day of the study or planned surgery within the first 52 weeks of the study, additionally, must not have exposure to certain medications/treatments (such as phototherapy within 4 weeks or TNF inhibitors, etc.) to be eligible for the study.
Psoriasis – registry
We are looking for patients 18 years and older with a diagnosis of psoriasis who are currently on or about to start taking a systemic biologic treatment for psoriasis. Registry studies do not provide any medications, but they do help us better understand the psoriasis disease process and various treatments.
Alopecia areata – topical treatment
We are looking for patients 18 to 70 years old who have been diagnosed with alopecia areata for 1-10 years, affecting 30% to 80% of the scalp for a phase 1b study with a novel topical medication that reduces inflammation. Participant must agree to maintain their hair style and color for the duration of the study. Participants cannot participate if they cannot discontinue systemic and/or topical therapies currently used for AA, if they are currently pregnant or breastfeeding, if they have been given prior JAK inhibitors, if they have been a smoker in the past 5 years, been a chronic alcohol or drug abuse user in the last 6 months or have other types of alopecia such as scarring.
Prurigo Nodularis
We are looking for patients 18 years and older with at least a 3-month history of prurigo nodularis for a phase 3 study with a topical JAK1 and JAK2 inhibitor cream. Subjects will apply the cream twice daily on the affected areas of PN during the study treatment period. Participants need to have at least 6 pruriginous lesions on at least two body sites (such as right and left leg) with an estimated body surface area (BSA) of 20% or less. Participants are excluded if their chronic pruritis is due to a condition other than PN, have a total body surface area of greater than 20% (excluding the scalp), have neuropathic and psychogenic pruritus, have active lesions of PN within 3 months of screening, or used a marketed or investigational biologic agent within 12 weeks of the study.
Hidradenitis Suppurativa (HS)
We are looking for patients 18-70 years old with moderate to severe hidradenitis suppurativa (HS) for a phase 2 study for the treatment of autoimmune and inflammatory diseases which pertain to HS in adults whom the symptoms are not controlled by current therapies. The experimental IRAK 4 degrader drug will be taken by mouth once daily. The drug works by reducing the amount of IRAK 4 in your cells, which likely will decrease the inflammation and normalize immune response with HS. Participants must have a history of signs/symptoms with HS for at least 1 year, must have at least two distinct anatomic areas (one of which must be Hurley Stage 2 or 3), and must have inadequate response to at least a 3-month treatment of oral antibiotics. Participants are excluded if they have a history of organ transplant, splenectomy, or any malignancy within the past 5 years (NMSC are allowed), and if they have used certain therapeutics in certain timeframes such as immunomodulators within 4 weeks, JAK inhibitors within 12 weeks, and lastly Anti-TNF, anti-IL17, or anti-IL1 therapy within 5 half-lives.
Squamous Cell Carcinoma
We are looking for participants with a historical diagnosis of cutaneous SCC based on skin biopsy with resectable stage I-III disease that measures (post-biopsy) equal to or smaller than 5mm and less than 100 mm in longest diameter for a phase Ib/II study that involves micro-needle array containing doxorubicin. We are looking for participants with expected survival greater than or equal to 12 months, that can meet pretreatment laboratory parameters (for example, platelets need to be greater than 50,000) and there is no evidence of infection. Participants are excluded if the tumor characteristics are >4 mm depth, Clark level IV, have perineural or lymphovascular invasion, on the ear or non-glabrous lip, are a size larger than 10 mm on neck/pretibial area or size larger than 20mm on trunk/extremities, have indistinct borders or rapid growth, or have the presence of neurologic symptoms. Participants are excluded from the study if they are pregnant or breast feeding.
cSCC, Melanoma, or Merkel Cell Carcinoma
We are looking for participants who are 18 years of age and older with Cutaneous SCC, melanoma, or Merkel cell carcinoma, meeting certain criteria (for example-cSCC resectable tumor must be stage 2 or lower) to participate in the dose escalation study of neoadjuvant intratumoral PH-762. PH-762 is a product that can increase the anti-tumoral activity of certain white blood cells called T-cells. Participants must have a minimum of one tumor greater than 1.0 cm but less than 3.0 cm that is accessible for intratumoral injection, biopsy, and excision, and must have a tumor that is not necrotic, hemorrhagic, or friable and is not within 2 cm of the eye, within 0.5 cm of the lip and is not in a mucosal or visceral location to be eligible for the study. Participants may not have any other malignancies within 3 years prior to screening (except for adequately treated BCC, SCC, superficial bladder cancer, or carcinoma in situ of prostate, breast, or cervix), be on any current chemotherapy, radiation, immunotherapy, or biologic therapy, and participants may not be pregnant/breastfeeding to be eligible for the study.
Melanoma
We are looking for participants who previously had or are planning soon to have a surgical resection of stage IIB, IIC, III, or IV cutaneous melanoma with histologically/pathologically confirmed diagnosis, to participate in this phase 3 study that involves pembrolizumab with individualized neoantigen therapy V490. To participate the subjects can’t receive any prior systemic therapy for the high-risk stage melanoma beyond surgical resection and must not let 13 weeks pass between their final surgical resection and the first dose of pembrolizumab. Participants are excluded if they have ocular/mucosal melanoma, if the cancer has spread to other parts of the body that cannot be removed with surgery, if they have received prior cancer therapy or if the participant had another cancer that spread to other parts of the body within the past 3 years.
Excision cosmetic outcome in patients with skin of color (SOC)
This study is investigating whether using fast gut or prolene suture during excisions has different cosmetic outcomes in patients with skin of color (SOC). Eligible patients include those with skin of color (see image below) that needs to undergo an excision at least 3 cm in length or Mohs. The excision can be on any site and with any suspected diagnosis (e.g., cyst removal, skin cancer excision, or other). If you have a patient that you think would be appropriate for this study or have any questions about the study, please reach out to Ashima Agarwal at asa115@pitt.edu or send Dr. Melissa Pugliano-Mauro a staff message in Epic. Surgeries will be performed at Shadyside, Falk, Brooktree or Harmar.
ECP Sezary
We are looking for participants who have been diagnosed with a form of cutaneous t-cell lymphoma called Sezary Syndrome with Extracorporeal photopheresis (ECP) treatment recommended, to participate in this open label, single-cohort, and single-center phase 2 study. The study will examine the effects of ECP on the immune response in one’s blood from before treatment up to 6 months of treatment. This study will help doctors better understand the effect of ECP on how your Sezary Syndrome responds to treatment and your immune systems response the cancer treatment.
SciTech
We are looking for participants 18 years or older who have a type of lymphoma that has become resistant to commonly available chemotherapy, or it has re-occurred after previous treatment, to participate in this study with a new drug called ST-001 that blocks the “on” signal to cancer cells, eventually causing them to die. It’s further believed that ST-001 can stimulate one’s immune system to recognize and attack your lymphoma cancer cells as well. ST-001 has active ingredient fenretinide which is like Vitamin A and will be administered at different doses via intravenous infusion. To participate you must discontinue all prior anti-cancer therapies for at least 4 weeks with all side effects resolved and must have a certain minimum of daily functioning. You cannot participate if you have other ongoing cancers that require treatment, the lymphoma has spread to CNS/brain, if you are pregnant/breastfeeding, used previous treatments with fenretindie, if your internal organs aren’t functioning well, if you have an allergy to any of the ingredients, if your doctor deemed that it’s not the most effective treatment or if you have serious medical problems that your doctor believes to be serious enough to make treatment with ST-001 unsafe (your doctor at their discretion can add any other reasons to why you can or cannot be enrolled in the study).
Contact Us About Participating in a Clinical Trial
A member of our team will be in touch with you within two business days.
Researchers
Joe K. Tung, MD, MBA, Director, Clinical Trials and Principal Investigator
Dr. Tung currently serves as the Medical Director of UPMC Falk Dermatology, Director of the Clinical Trials Unit, and Associate Director of the Dermatology Residency Program. Dr Tung sees patients at the Falk Dermatology Clinic in Oakland.
Additional research staff:
- Emily Clark, PA-C, Sub-Investigator
- Timothy J. Patton, DO, Sub-Investigator
- Charity Ruhl, LPN, Study Coordinator
- Megan Sullivan, BS, Study Coordinator
- Carley Clark, BS, Study Coordinator
- Julie Campbell, MPH, Study Coordinator
- Anna Davis, MD, Study Coordinator
Locations
Falk Medical Building
Fifth Floor
3601 Fifth Ave.
Pittsburgh, PA 15213
412-647-2013 Phone
412-647-4832 Fax