Treatment Trials

43 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
The Effects of Zinc Di-(Dibutyryl Lisinate) on Skin Health and the Skin Microbiome in Photoaged Skin
Description

This study is a double-blind randomized vehicle-controlled study assessing how Zinc Di-(dibutyryl lisinate) (Z-DBL) influences skin biophysical measures such as skin hydration, transepidermal water loss, and elasticity, as well as its effects on the skin microbiome of photoaged skin.

Conditions
RECRUITING
Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
Description

The purpose of this study is to assess the safety of the skin balancing gel cream and examine the effects it has on the skin microbiome of individuals with non-cystic acne prone skin.

COMPLETED
Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
Description

The overall objective of this study is to assess how the use of the drug may shift the skin microbiome and skin biophysical properties. Specifically, the study objectives were to assess the following: * How the drug affects the skin microbiome compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea. * How the drug affects the skin physical properties compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.

COMPLETED
Effect of an Antiseptic Solution on the Skin Microbiome
Description

The objective of this study is simulate the clinical use of an antiseptic solution in a 24 hour window and the recovery to baseline conditions at 1 month following application. Efficacy will be simulated as the capacity of the material to reduce or clear the skin bacterial population from a representative skin area: the anteromedial forearm.

UNKNOWN
Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)
Description

This is a single-center, randomized, blinded, controlled trial assessing the effects on the skin microbiome in patients with eczema of amending a standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO)

Conditions
COMPLETED
Characterizing Skin Microbiome Change in Atopic Dermatitis
Description

Atopic dermatitis (AD), also known as eczema, is an inflammatory disease of the skin affecting a large proportion of the pediatric and adult patient population. Chronic itching and eczematous lesions lead to a high burden of disease and associated patient morbidity with higher infection rates, emotional stress and associated psychological disease. The microbiome community contributes to human health through several mechanisms. Current research suggests that derangements in the normal microbiota may lead to inflammatory bowel disease, allergy, and metabolic syndromes. Specific to dermatology, new literature has demonstrated that changes in the microbiome may play a role in the development of atopic dermatitis. With this study, the investigators hope to characterize the baseline atopic dermatitis skin microbiome and monitor the evolution of the participants skin microbiome during and after treatment with anti-inflammatory topical medications, specifically the Food and Drug Administration (FDA)-approved phosphodiesterase inhibitor, crisaborole ointment 2% (Eucrisa).

COMPLETED
Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Description

The study objective is to characterize the shift in the diversity and abundance of the skin microbial community at baseline and in response to Altreno monotherapy as compared to benzoyl peroxide (BPO) 2.5% leave-on gel monotherapy in acne patients.

Conditions
COMPLETED
Interactions Between Skincare Product Ingredients and the Skin Microbiome
Description

This is a study of the influence of skincare products containing chemicals such as parabens and phthalates on the skin microbiome.

Conditions
RECRUITING
Study of Skin Microbiome in AD and PS Patients
Description

Everybody's skin has bacteria that normally lives on it. Previous research has shown that people with eczema (or atopic dermatitis \[AD\]) have much higher concentrations of a certain bacteria (S. aureus), especially when their disease is active but little is known about the role that this bacteria plays in psoriasis (i.e. disease severity, biomarkers and skin barrier function). The overarching purpose of this longitudinal study is to understand how the abundance of skin S. aureus (and several commensal bacteria) change as a consequence of standard of care treatment in the URMC dermatology clinics. Other assays and biospecimens will also be collected to address a number of questions.

COMPLETED
The Influence of Personal Care Products on the Skin Microbiome
Description

To evaluate whether personal care products shift the skin microbiome bacteria and diversity after a week of daily use.

Conditions
COMPLETED
Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch
Description

This was a multi-center, 14-day clinical use study with a 7-day regression period, being conducted to assess the changes in the skin microbiome with two moisturizers in female and male subjects 16-50 years of age with mild to moderate eczema that experienced a recent itch flare up.

Conditions
RECRUITING
The Gut and Skin Microbiome in Vitiligo Disease Progression
Description

Investigators plan to perform a pilot study that aims to characterize the microbiome of human vitiligo patients with both active and stable disease and compare this to the microbiome of age and sex matched controls. The investigators aim to answer the question whether the gut and skin microbiome of patients with vitiligo differs from the general population.

Conditions
COMPLETED
Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis
Description

The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.

Conditions
COMPLETED
Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds
Description

This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin physiology assessments will be completed.

COMPLETED
Effect of Surfactants on the Skin Microbiome
Description

Up to 10 volunteers will be recruited to evaluate the microbial environment on their forearms. Following informed consent, bacterial swabs will be obtained at baseline from the forearms of all subjects. Their forearms will then be washed with one of the study cleansers. Subjects will then have their forearms swabbed for bacteria at the following time points: 10 minutes, 6 hours, and 24 hours after the wash. DNA will be extracted from all swabs and bacterial diversity evaluated by 16S pyrosequencing.

Conditions
WITHDRAWN
Study of the Human Skin Microbiome
Description

Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin.

Conditions
WITHDRAWN
The Effect of Surfactants on the Bacterial Composition of the Layers of the Skin
Description

Recent research in the investigator's lab has shown that bacteria are present not only on the outer surface of our skin, but also in the deeper components as well. In this study, the investigator will study the bacteria present in different components of the skin including the epidermis, dermis, subcutaneous fat, and hair follicle, and determine if and how these bacteria change after repeated use of different commercially available hand soaps. It is expected that the bacteria populations in the different skin components will change with the use of different soaps.

WITHDRAWN
Microbiome Survey of Preterm Infants
Description

The skin and intestinal tracts of humans are covered with microbes, and the gene products of these microbes are collectively known as the human microbiome. Many studies in recent years have linked the microbiome to many aspects of human health and disease. Premature infants are vulnerable to invasive infections, some of which may originate from the microbes that colonize the skin and in the intestinal tract. Therefore, determining the patterns of early life colonization and the sources of colonization in these infants may be critical to determining infectious risks. This prospective study is proposed to identify the sources of microbes that colonize extremely low birth weight (ELBW; \<1000 g birth weight) infants immediately following birth through the first month of life. The study team plans to non-invasively survey the skin and stool of ELBW preterm infants in combination with sampling of their mothers' skin and stool and the intensive care nursery (ICN) environment. As controls, the study team will perform a similar survey of full term mother-infant pairs. Samples will be analyzed using high throughput sequencing techniques to determine microbial content. Topical barrier sprays or emollients are commonly used early in life in the ELBW infant to reduce insensible water loss and enhance the integrity of the skin barrier. The effect of these treatments on the development of the skin microbiome remains unknown. As part of this study, the study team also proposes the application of two different skin barrier therapies to small areas on infant's legs to determine the effects of the different treatments on skin colonization. While all parts of the study are described in this summary and the detailed description, the remainder of the record focuses on this interventional portion of the study (Group 2). The goals of this study are outlined as follows: 1. To elucidate the relationship between microbes in the health care environment and colonization patterns of the intestinal tracts in preterm and term infants. 2. To understand the relationship between mode of delivery, the health care environment, and the colonization of the skin in preterm and term infants. 3. To determine the effects of topical skin barrier therapies on the colonization patterns of the skin in preterm infants. 4. To ascertain the relationship between the composition of the microbes colonizing preterm and term infants and the development of mucosal and systemic immunity to those microbes.

Conditions
COMPLETED
The Influence of Oral Probiotics on the Microbiome and Lipidome
Description

The purpose of this study is to measure oil production of the face, facial properties, and gut bacteria in people being given oral probiotics. Probiotic supplements contain active cultures of bacteria that are thought to be beneficial to human health.The investigators want to find out if probiotics taken by mouth alter the bacteria in subject's gut and subject's skin oil production compared to a placebo. This is a single blind study and subject may receive a probiotic or a placebo for the first half of the study and a placebo or a probiotic for the second half of the study. Subject will not know what was given to participants.

COMPLETED
The Effect of Isosorbide Diesters Based Moisturizer on Skin Health
Description

The overall objective of this study is to assess how a natural ingredient, isosorbide diesters (IDEAS), works in association with colloidal oatmeal for eczema.

RECRUITING
Analysis of the Microbiome in Rosacea
Description

The skin and gut microbiome of rosacea patients differs from individuals without rosacea and that the microbiome suffers from unique derangements in rosacea patients following antibiotic therapy. This study was proposed to examine microbial signatures of the skin and gut microbiome in patients with moderate to severe rosacea and to identify differences between microbe communities in patients with rosacea and volunteers without rosacea using 16S ribosomal ribonucleic acid (rRNA) polymerase chain reaction (PCR) amplification, sequencing and computational phylogenetics and to assess alterations in the gut and skin microbiota of patients with moderate to severe rosacea in response to varying formulations of antimicrobial treatment.

Conditions
TERMINATED
A Study of a Baby Wash/Shampoo and Baby Lotion Versus Baby Wash/Shampoo Alone for Impact on Skin Barrier and Microbiome on Newborns
Description

The purpose of this study is to demonstrate the tolerance of a baby wash/shampoo alone and the tolerance of a regimen of a baby wash/shampoo and baby lotion in a newborn population.

Conditions
UNKNOWN
Oral Probiotics on the Shift in Gut Microbiome and Skin Carotenoid Levels
Description

The purpose of this study is to determine how probiotics affects circulating carotenoid levels.

COMPLETED
The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties
Description

The purpose of this study is to assess the use of oral Terminalia chebula fruit extract on the gut microbiome and skin biophysical properties. The fruit is commonly used for skin treatments in India. It is thought to have antioxidant properties, reduce inflammation and affect the microorganisms in the gut. The information the investigators will learn from this study may indicate how and if oral dosing can affect the skin and gut microbiome. This may lead to an improved understanding of the skin and determine whether these oral products are effective for improving the skin's appearance.

COMPLETED
Oral Pomegranate Extract on the Microbiome and Skin Biophysical Properties
Description

Pomegranate extract (Pomella) is well known for its antioxidant properties due to its phenolic compounds. It has also been shown to increase the amount of short chain fatty acid producing Lactobacillus and Bifidobacteria genera. Short chain fatty acids are thought to have an anti-inflammatory effect on the sebaceous glands. Previous studies have concluded that pomegranate extract may act as a prebiotic in the body and subsequently increasing the gastrointestinal microbial diversity and by producing short chain fatty acids that may have systemic beneficial effects especially on the skin. Therefore, the aim of this study is to assess how Pomella alters the gut microbiome and the blood level of short chain fatty acids in healthy subjects.

COMPLETED
Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin
Description

Few studies have assessed the effects of Triphala and Rubia Cordifolia from a skin biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.

UNKNOWN
Botanical Blend on the Gut Microbiome and Gut-Skin-Axis in Small Intestinal Bacterial Overgrowth (SIBO)
Description

The purpose of this study is to assess how an oral botanical blend alters the gut microbiome and the skin biophysical properties in people with SIBO.

NOT_YET_RECRUITING
Pilot Study to Characterize the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of CLn® Skin Care Body Wash
Description

In this pilot study of patients with mycosis fungoides, the most common form of CTCL, we propose to primarily evaluate the impact of daily use of the CLn Body Wash (dilute sodium hypochlorite (0.006% NaOCl)) on the microbiota of CTCL lesions. Should dilute sodium hypochlorite body wash improve the microbiome of MF, reducing the abundance of S. aureus, future, larger studies can more fully evaluate the impact on pruritus, erythema, scaling, disease evolution and its role in CTCL management.

NOT_YET_RECRUITING
Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Description

This open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of APR-TD011 ((RLF-TD011) wound cleansing spray for the treatment of CTCL skin lesions.

RECRUITING
Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health
Description

The objective of the proposed research is to determine the effects of fresh mango consumption on gut microbiome, and its relationship with skin health, sexual and mental health in relatively healthy adults.

Conditions