RECRUITING

Effects of Treatments on Atopic Dermatitis

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Conditions

EczemaDermatitisSkin Diseases, GeneticDermatitis, AtopicSkin DiseasesInvestigator-BlindedSkin BiopsyRandomizedAntibioticsTopical

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: \- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S. aureus bacteria. Researchers want to study how eczema treatments affect the number and the type of bacteria on the skin. Objectives: \- To study the effect of eczema treatments on skin bacteria. Eligibility: * Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis. * Healthy volunteers between 18 and 40 years of age with no history of eczema. Design: * Participants will be screened with a physical exam and medical history. Research samples will be collected. Skin biopsies may also be performed. * All participants will be assigned to one of several study groups. * Healthy volunteers must not have taken antibiotics in the year before the start of the study. * All participants will have regular study visits during their 1-year participation. More research samples will be collected at these visits. * Healthy volunteers may be asked to come in for a one-time follow up after the 1 year mark.

Official Title

Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis

Quick Facts

Study Start:2012-09-18
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01631617

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females aged 18-50 years at time of initial protocol sampling
  2. * Subjects must participate fully and be willing to comply with the procedures of the protocol
  3. * Subjects must be co-enrolled in NIH protocol 08-HG-0059
  4. * Ability of subject to understand and provide written informed consent
  5. * Access to bathing facilities (Cohort 2 \[INACTIVE\])
  6. * Ability to swallow capsules or tablets
  7. * Subjects must be aged 2-50 years
  8. * Subjects must be co-enrolled in NIH protocol 08-HG-0059
  9. * Subjects must have a diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party s Diagnostic Criteria for Atopic Dermatitis
  10. * Subjects must have a primary care provider
  11. * Subjects must have an Objective SCORAD (SCORing Atopic Dermatitis) of greater than or equal to 15 indicating AD severity of moderate to severe
  12. * Prior to initiation of randomized treatment, subjects must have signs of bacterial skin infections (skin weeping, crusting, and/or pustules)
  13. * Access to bathing facilities
  14. * All subjects and/or their Legally Authorized Representative (LAR) must have the ability and agree to participate fully and comply with
  15. * Subjects previously enrolled in Cohorts 1 \[NO FURTHER ACCRUAL\] and 4 \[INACTIVE\] who completed on-protocol antibiotic regimen
  16. * Subjects must participate fully and be willing to comply with the procedures of the protocol
  17. * Ability of subject to understand and provide written informed consent
  1. * Does not meet inclusion criteria
  2. * Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause
  3. * Use of systemic antibiotics in 12 months preceding baseline sampling
  4. * Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling
  5. * Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment
  6. * Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; or lidocaine or epinephrine
  7. * Family history of toxic epidermal necrolysis
  8. * Known allergy or sensitivity to sodium hypochlorite (NaOCl)
  9. * History of AD or asthma
  10. * Inability to comply with the requirements of the protocol
  11. * Pregnant or lactating
  12. * Subjects with a primary or acquired immunodeficiency, including HIV seropositiviy
  13. * Any chronic past or present medical illness, including chronic skin diseases like psoriasis
  14. * Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants
  15. * Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as, assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals
  16. * Does not meet inclusion criteria
  17. * Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause
  18. * Known allergic reaction to beta-lactam class drugs, lidocaine, or epinephrine
  19. * Family history of toxic epidermal necrolysis
  20. * Known allergic reaction to sodium hypochlorite (NaOCl)
  21. * Use of systemic antibiotics within 8 weeks, or topical antibiotics on intended sampling sites within 3 weeks, prior to baseline sampling
  22. * Use of topical corticosteroids on all intended sampling sites within 7 days, prior to baseline sampling
  23. * Use of topical or oral CAM agents within 4 weeks of initiation of treatment
  24. * Subjects with known primary or acquired immunodeficiency
  25. * Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the initial month of the study or who have been hospitalized for treatment of these conditions in the one month prior to baseline sampling
  26. * Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants within 7 days or 5 half-lives (whichever is the longer time period) of initiating treatment on this protocol
  27. * Subjects who are currently receiving or have received chemotherapy or radiation for treatment of malignancies within the previous 6 months
  28. * Pregnancy or lactating
  29. * Does not meet inclusion criteria
  30. * Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause
  31. * Use of systemic antibiotics in 12 months preceding baseline sampling
  32. * Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling
  33. * Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment
  34. * (Cohort 4 \[NO FURTHER ACCRUAL\]) Known allergic reaction to sulfa class drugs; or lidocaine or epinephrine
  35. * (Cohort 5 \[INACTIVE\]) Known allergic reaction to tetracycline class drugs; or lidocaine or epinephrine
  36. * Family history of toxic epidermal necrolysis
  37. * History of AD or asthma
  38. * Inability to comply with the requirements of the protocol
  39. * Pregnant or lactating
  40. * Subjects with a primary or acquired immunodeficiency, including HIV seropositivity
  41. * Any chronic past or present medical illness, including chronic skin diseases like psoriasis
  42. * Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants
  43. * Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals
  44. * Does not meet inclusion criteria
  45. * Use of swimming pools, hot tubs, or whirlpools in 7 days preceding sampling
  46. * Use of topical or oral CAM agents within 1 week or 4 weeks, respectively, prior to sampling
  47. * Pregnant or lactating females in all cohorts are excluded from participating due to the potential effects of the above listed antimicrobials on the developing human fetus or nursing infant; listed in Sections 11.1 through 11.5. Females of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Lactating mothers will discontinue breastfeeding prior to study enrollment.
  48. * Smokers and subjects who use smokeless tobacco products are excluded in all cohorts due to tobacco s unknown impact on human oral mucosa and microflora.

Contacts and Locations

Study Contact

Monica E Taylor, R.N.
CONTACT
(301) 451-2221
monica.taylor@nih.gov
Heidi H Kong, M.D.
CONTACT
(301) 827-2460
konghe@mail.nih.gov

Principal Investigator

Heidi H Kong, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  • Heidi H Kong, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-09-18
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2012-09-18
Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

  • Investigator-Blinded
  • Skin Biopsy
  • Randomized
  • Antibiotics
  • Topical

Additional Relevant MeSH Terms

  • Eczema
  • Dermatitis
  • Skin Diseases, Genetic
  • Dermatitis, Atopic
  • Skin Diseases