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Search Results Within Category "Skin Conditions"

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10 Study Matches

A Multicenter, Open-Label, Single Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (aged 2 to 11 years) with Moderate-to-Severe Atopic Dermatitis

Atopic Dermatitis: Open Label, 64 weeks study. Injectable medicine. Males/Females 2-11 years with moderate to severe atopic dermatitis. The goal of the study is assess the uptake of the drug by the body and safety of nemolizumab administered with topical corticosteroids.

Participants will attend in person visit at the Dermatology Clinical Trial office. Dr. Zaenglein is the pediatric dermatologist in charge of this research study and will do all skin evaluations. In addition at different time points there will be blood that is drawn, questionnaires to be completed, and ECGs will be performed.

Study coordinator will discuss.

Yes
 

Andrea Zaenglein
Amy Longenecker - at alongenecker@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

Female
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT04921345
SITE00001016
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Inclusion Criteria:
Ages 2-11 years old
Diagnosed with Moderate to Severe Atopic Dermatitis
Willing to attend all study visits and follow directions

Exclusion Criteria:
Certain treatments for atopic dermatitis are not allowed; study coordinator will discuss
Had a documented asthma exacerbation requiring hospitalization in the past 12 months.
Weigh less than 22 pounds
Skin Conditions
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Hershey, PA ,

SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations

Microcystic lymphatic malformations (mLMs) are masses of spongy tissue that may have small fluid-filled cysts. They are made of abnormally large or misshapen lymph vessels that do not work correctly. They are usually present at birth and get worse over time. Complications of mLMs include infection, bleeding, leaking of lymphatic fluid, disfigurement, and impaired mobility. The purpose of this study is to find out if the study medicine, sirolimus 3.9% topical gel, can help with the treatment of mLMs.

Total duration of the study is approximately 14 months, with up to 8 visits (approximately 1 visit per month). 5 visits will occur in person and 3 visits will be phone call visits. You will also complete 2 interviews. After the first 14 months, you will have phone call visits every 84 days until either the study is discontinued, or you decide to no longer participate. Procedures involved in the study include: medical history collection, physical exams, skin assessments, patient interviews, photographs, blood draws (at 3 visits), urine tests, and questionnaires.

Yes
 

Andrea Zaenglein
DermatologyClinicalTrials@pennstatehealth.psu.edu 717-531-5136
Dermatology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06239480
STUDY00024161
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Inclusion Criteria:
Confirmed diagnosis of microcystic lymphatic malformation
At least 6 years old
Willing to follow all study guidelines

Exclusion Criteria:
Certain treatments are not allowed; coordinator will discuss specific treatments
History of HIV or other immunodeficiency
Skin Conditions
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Hershey, PA ,

Hidradenitis Suppurativa: Evaluation of Upadacitinib in Adult and Adolescent Subjects

Phase 3, global, randomized, double-blind, placebo-controlled, multi-center study that will evaluate upadacitinib in the treatment of moderate to severe HS in adult and adolescent subjects who have failed to respond to or are intolerant of ant-TNF therapy and/or 1 approved non-anti-TNF-biologic therapy for HS.This study is comprised of a 35-day screening period, a 16 week placebo-controlled, double-blinded treatment period (Period 1), a 20-week re-randomized extension treatment period (Period 2), a 68-week long-term extension treatment period (Period 3) and a 30-day follow-up period.

You will completed 3 study periods over approximately 104 weeks. During that time at different time points you will have your skin examined, ECG, complete questionnaires, and have your labs drawn. In addition you will take the study medication as directed by the research study coordinators.

Yes
 

Andrea Zaenglein
Dermatology Clinical Trials - at dermatologyclinicaltrial@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT05889182
SITE00001422
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Inclusion Criteria:
12 years of age and older
2 active HS areas
History of previous use ≥ 1 TNF inhibitor for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks - study coordinator will discuss
Must agree to use daily wash

Exclusion Criteria:
Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded. - Study coordinator will discuss
Skin Conditions
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Gorlin Syndrome

Participants 18 years and older who meet the diagnostic criteria for the basal cell nevus (Gorlin) syndrome will be assigned to receive either Patidegib Gel 2% or Placebo (no active medicine) to apply twice daily for 12 months. The assignment will be made according to sex assigned at birth, age, and number of BCC lesions at the treatment area at Baseline. The primary endpoint is a comparison between the 2 treatment arms of the number of new BCCs at Month 12 compared to Baseline. The BCCs will be imaged and tracked consistently throughout the study to identify new BCCs and to confirm their diagnosis by dermoscopy (handheld instrument with a 15x magnification lens and a cross-polarized light source).

Participants will participate in 15 visits over approximately 14 months (attend 6 in person visits along with 9 phone call visits). In addition, participants will receive study medication to apply twice a day for 12 months and undergo clinical tests at various time points, which include blood tests, ECG, complete questionnaires/diary, skin exam and skin photographs.

Compensation is provided for eligible participants.

Yes
 

Elizabeth Billingsley
Samantha Gettle - at dermatologyclinicaltrials@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06050122
STUDY00023809
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Inclusion Criteria:
Must be confirmed to have a PTCH1 mutation
Diagnostic criteria present for Gorlin Syndrome
10 BCCs present on face at Randomization (Baseline/Day 1)

Exclusion Criteria:
Certain medications are not allowed during study; study coordinator will discuss
uncontrolled systemic disease
uncontrolled skin disease on the face.
Skin Conditions
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Defining the cellular and molecular signatures that are associated with the clinical heterogeneity of hidradenitis suppurativa

Patients with the clinical diagnosis of mild, moderate to severe Hidradenditis Suppurativa or normal healthy volunteers ages 18 and older to participate in a 1 time study visit. There is no treatment provided but we may gain information for the treatment of HS.

Eligible participants will attend a one time in person visit. During the visit, the study team will ask you to participate in the following activities: collect skin sample, blood sample and cheek swab. Take photographs of your HS lesions.

study coordinator will discuss.

Yes
 

Amanda Nelson
Amy Longenecker - at alongenecker@pennstatehealth.psu.edu or 717-531-1513
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012908
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Inclusion Criteria:
18 years and older
Hidradentitis Suppurativa diagnosis for 3 months
Normal skin participants

Exclusion Criteria:
Patients who are Pregnant
Normal skin participants do not have an autoimmune disease
Participants who do not want to have any of the lesion sampling performed
Skin Conditions
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Hershey, PA ,

Exploratory Trial of Ruxolitinib 1.5% Cream for Early Stage Hidradenitis Suppurativa

Explore all stages of Hidradenitis Suppurativa with a topical medication.

There will be 7 in-person visits and 1 follow-up phone call over a 33 week period. Over the course of the study, the following study procedures will take place: medical history and medication history collection, ECG, lab tests (both blood and urine), photography, skin exams, physical exams, questionnaires, and skin biopsies.

Up to $350

Yes
 

Andrea Zaenglein
Amy Longenecker - at alongenecker@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04414514
STUDY00016042
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Inclusion Criteria:
Must have diagnosis of HS for at least 3 months (90 days)
Must have active HS in at least 1 area
Must have negative TB screening assessment
Certain medications can be continued if on stable dose; study coordinator will discuss further.

Exclusion Criteria:
Any other active skin disease or condition that may interfere with assessment of HS
Pregnant (or considering becoming pregnant) or lactating females
Does not have reliable internet access for weekly electronic surveys
Skin Conditions
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Hershey, PA ,

Assessing the impact of post-inflammatory hyperpigmentation on quality of life in people of color

This survey study is looking to see how post-inflammatory hyperpigmentation (PIH) affects quality of life in people with skin of color.

Participants will complete a one-time survey that will ask about post-inflammatory hyperpigmentation.

No
 

Lauren Hollins
Tierney Wallace - at twallace3@pennstatehealth.psu.edu or 717-531-6117
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00021979
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Inclusion Criteria:
Ages 18-89
Experienced/experiencing post-inflammatory hyperpigmentation

Exclusion Criteria:
Individuals with acanthosis nigricans
Individuals who are not able to understand English
Skin Conditions
Survey(s)
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Skin pathophysiology of Hidradenitis Suppurativa

The purpose of this research study is to collect skin samples from volunteers with HS and volunteers with healthy skin. The collected skin samples will be processed and compared to each other to see if there are specific differences in the skin between the HS volunteer group and the healthy skin volunteer group.

Participants will need to come to a one-time, in-person visit where biopsies (small skin samples) will be collected.- For participants with HS: Up to 4 biopsies will be collected - For participants with healthy skin: Up to 2 biopsies will be collected

Yes
 

Amanda Nelson
Samantha Gettle - at sgettle2@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020589
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Inclusion Criteria:
Diagnosis of hidradenitis suppurativa (HS)
HS lesions present in the armpits and/or groin

Exclusion Criteria:
Participants who are pregnant or are planning to become pregnant
Certain medications are not allowed in this study- the study team will provide details
Skin Conditions
Not applicable
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Hershey, PA ,

Exploring Genetic Correlates of Facial Diversity Among Afghanistan's Major Ethnic Groups

Our first, aim is to quantify the superficial traits among the Hazara, Tajik, and Pashtun populations of Afghanistan by using a computer-based 3D morphometric method. We want to quantify the facial traits, voices and pigmentation, identify genetic regions affecting these traits, and plot phylogenetic trees to explain the probable facial variation and evidence of shared genetic basis they might exhibit across population. The expected number of participants in the study will be ~ 500 individuals which will provide us a better understanding of the evolution of superficial traits among these Afghan ethnic groups. This will be the first study to focus on Afghanistan's population which will provide important insights into a diverse and understudied set of human populations. As a result, a more comprehensive examination of facial genetics could be performed. Our second aim for the study is to uncover which genetic variants affect superficial trait variation by using next-generation sequencing (NGS). To achieve this goal, human saliva samples will be collected which will undergo genetic laboratory procedures for DNA extraction, amplification, quantification, and genotyping. The finding will help us to learn more about the qualitative and quantitative facial genetic variability. We hypothesize that facial variability among Hazara, Tajik, and Pashtun is greater than expected which can lead us to other questions about ancestry, migration, and human evolution. From their geographic proximity genetic and computational analysis will allow us to answer the question of how facial pigmentation and vocal variation among these populations leads to genetic diversity. Climate, migration history, and mate choice are the major contributors to phenotypic variation in the population. Our qualitative and quantitative data will be the best source of understanding facial morphological variation across populations, and how past migration affects gene flow, which has a direct effect on these traits which evolved jointly and differently in each population. Our third aim for this project is to look for forensically important markers that can contribute to the field of forensic genetics and enhance law enforcement and forensic investigations. The discovery of novel forensically important markers that can shape phenotypic variation will make major contributions to the field of forensic anthropology. The fourth and final objective of this research is to determine how human migration affects the variation of the oral microbiome and the subsequent effects of this diversity on human well-being, diet, energetics, and microbial genus.

Our team is visiting the participant location to collect hair, voice, saliva, and 3D images. It will take 30 minutes for each participant to complete the entire activity.

Yes
 

Muhammad Shirzad
Muhammad Rehman Shirzad - at mrs6995@psu.edu or 202-769-9909
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024624
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Inclusion Criteria:
Adults aged between 18 – 65 years.
Participants must have the legal capacity to provide autonomous, voluntary consent.
Participants must identify with either of the Pashtun, Hazara, and Tajik ethnic groups of Afghanistan.
Participants with no facial dysmorphology (any condition, such as major facial surgical intervention, that may result in facial dysmorphology), conspicuous make-ups, conspicuous facial hair, conspicuous tribal marks, or religious facial covering.
The participant must be residing in the United States.

Exclusion Criteria:
Individuals who are less than 18 years of age at the time of enrollment will not be allowed to participate in the study. Individuals who are not Afghan citizens may not participate in the study.
Males with facial hair who are unwilling to shave for the enrollment appointment may not participate in the study.
Individuals with tribal marks or history of facial reconstructive surgery shall be excluded from this study. Females with religious covering who are unwilling to remove the same shall be excluded from the study.
Individuals who have adverse reactions to bright lights or flash photography may not participate in the study.
Pregnant women will be excluded. Individual which are close relative e.g., Siblings.
Skin Conditions, Education, Language & Linguistics
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State College, PA ,

A Confirmatory Phase 3 Mutlicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL).

The purpose of this trial is to evaluate the safety and efficacy of 18 weeks of HyBryte (topical gel) treatment in combination with visible light therapy in subjects with cutaneous T-cell lymphoma when compared to placebo (no active ingredient). Cutaneous T-cell lymphoma (CTCL), of which the most common early stages are also known as mycosis fungoides (MF), is the most common type of T cell lymphoma. Participants will be enrolled in this trial for 30 weeks and will follow up at the clinic site every 4 weeks following the last trial treatment for a total of 12 weeks.

Participants will attend in person visits over 30 weeks. At different timepoints throughout the study participants will have their skin evaluated and photographed, have blood drawn, have an ECG done, and apply the study medication as directed by the study team.

Yes
 

Christopher Bazewicz
Samantha Gettle - at dermatologyclinicaltrials@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06470451
STUDY00025614
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Inclusion Criteria:
Participants must have a clinical diagnosis of CTCL (MF)
Participants must have a minimum of 3 evaluable, discrete lesions
Participants must be willing to follow the clinical protocol and voluntarily give their written informed consent

Exclusion Criteria:
Certain medications are not allowed to be used during the study; study coordinator will discuss.
Participants with extensive skin disease may not be eligible to participate; investigator will discuss during skin evaluation
Certain medical conditions may not be eligible to participate; study coordinator will discuss further.
Skin Conditions, Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,