Is NCT06096857 recruiting in Bethesda, MD?

Yes, NCT06096857 is currently recruiting participants at its Bethesda, MD location. This atopic dermatitis clinical trial is actively enrolling qualified participants.

How do I join the atopic dermatitis clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Atopic Dermatitis Clinical Trial in Bethesda, MD

About This Atopic Dermatitis Study in Bethesda

Background: Atopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep problems. No cure exists for AD. Researchers know that people with AD have different kinds of harmless bacteria on their skin than do people without AD. They want to see if adding a harmless bacteria (Roseomonas mucosa) to the skin can help people with AD. Objective: To test a skin treatment that contains R. mucosa and ground cardamom seeds in people with AD. Eligibility: People aged 2 years and older with AD. Design: All study visits will be remote. Participants will have 5 visits over about 7 months. Participants will be screened. Researchers will review their AD and medical history. Participants will receive a study product in the mail. The product comes as a powder in single-use packets. Participants will be shown how to mix the powder with water in a single-use spray vial. They will spray the solution onto their skin 2 to 3 times per week for 14 weeks. Half of participants will receive the study powder. Half will receive a placebo; the placebo looks just like the study powder but contains no bacteria. They will not know which one they have. During 3 study visits, participants will take a skin swab. They will receive supplies in the mail to rub a cotton swab on their skin and mail it back to the researchers. Participants may opt to have pictures taken of their AD. Participants will fill out 4 online questionnaires.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

To be eligible to participate in this study, an individual must meet all of the following criteria:

Aged \>=2 years

Have a documented primary care provider near residence

Fluency in English (applicable to participant or caregiver who will be answering questionnaires)

Clinical diagnosis of AD, as defined by Hanifin and Rajka criteria, that has been present for \>=3 months before the screening visit

Major Criteria: Must have \>=3 basic features:

Typical morphology and distribution (flexural lichenification in adults, facial and extensor eruptions in infants and children)

Chronic or chronically relapsing dermatitis

Personal or family history of atopy (asthma, allergic rhinitis, AD)

Minor Criteria: Must have \>=3 minor features:

Ichthyosis/palmar hyperlinearity, keratosis pilaris

Immediate (type 1) skin-test reactivity

Raised serum IgE

Early age of onset

Tendency toward cutaneous infections (especially Staphylococcus aureus and herpes simplex), impaired cell-mediated immunity

Tendency toward non-specific hand or foot dermatitis

Nipple eczema

Recurrent conjunctivitis

Dennie-Morgan infraorbital fold

Keratoconus

Anterior subcapsular cataracts

Orbital darkening

Facial pallor, facial erythema

Pityriasis alba

Anterior neck folds

Itch when sweating

Intolerance to wool and lipid solvents

Perifollicular accentuation

Food intolerance

Course influenced by environmental or emotional factors

White dermographism, delayed blanch

EASI \>5 and/or an IGA \>=1 at time of enrollment.

Sexually active participants of childbearing potential must agree to use adequate methods of contraception from the screening visit continuously until 30 days after stopping treatment with the investigational product. Childbearing potential is defined for children as participants who have begun menstruating and for adults as participants who are not surgically sterile (hysterectomy and/or tubal ligation) or menopausal (age \>=45 years plus no menses for 12 consecutive months without an alternative medical cause). Adequate contraception methods include: a barrier method (eg, condom use), oral contraceptive pill, hormonal patch or ring, hormonal injection, parenteral hormonal implant, or an intrauterine device.

Participants and parents/legal guardians (for minor participants) are willing and able to comply with all study visits and/or study-related procedures.

Participants/parents/guardians must have the ability to provide informed consent/assent as applicable.

Willingness to perform visits virtually.

Exclusion Criteria

Previous treatment of AD:

Within 4 weeks prior to the baseline visit with any of the following:

Immunosuppressive or immunomodulating systemic drugs such as systemic corticosteroids, azathioprine, methotrexate, cyclosporine

Phototherapy or photochemotherapy for AD

Within 12 weeks prior to the baseline visit with any of the following having been newly initiated:

Topical steroids or topical calcineurin inhibitors

Janus kinase (JAK) inhibitors (oral or topical)

Dupilumab or any other biologic agent

Topical PDE4 inhibitor

Emollients containing ceramides, hyaluronic acid, urea or filaggrin degradation products.

Bleach baths

Active infection (chronic or acute) requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the baseline visit.

Superficial skin infection requiring topical treatment within 1 week of baseline visit.

Known or suspected history of immunosuppression or immunodeficiency.

Existence of indwelling central line.

Co-habitation with someone that has a known or suspected history of immunosuppression or immunodeficiency or has a central line.

Any clinically significant laboratory, history, or exam findings that, in the investigator's opinion, would suggest an increased risk to the participant.

Self-reported pregnancy or breastfeeding.

Menstruating females who have not menstruated within 6 weeks prior to screening. Participants who have an intrauterine device or implanted long-term contraceptive agent that prevents them from menstruating regularly will not be excluded.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT06096857) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Atopic Dermatitis Treatment Options in Bethesda, MD

If you're searching for atopic dermatitis treatment options in Bethesda, MD, this clinical trial (NCT06096857) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced atopic dermatitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all atopic dermatitis clinical trials near you to find additional studies recruiting in your area.

Atopic Dermatitis Clinical Trial in Bethesda, MD

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