Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis

NCT03018275 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17003317-I-0033
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Atopic dermatitis (AD) is a skin disease also called eczema. It is common in children and sometimes gets better on its own. However, chronic AD may cause asthma, food allergies, eye infections, and sleep problems. The cause of AD might be related to bacteria that live on the skin. Researchers want to see if introducing bacteria, R mucosa, from healthy skin onto the skin of someone with AD helps treat the disease. Objective: To test the safety and activity of R mucosa for treating AD. Eligibility: Part 1: People ages 18 and older with AD Part 2: Children ages 3-17 with AD Design: Participants will be screened with: Medical history Physical exam Examination of their AD Blood and urine tests At the baseline visit, participants will have blood tests and photos taken of their skin. They will get a supply of R mucosa and a memory aid to track their doses and record how they are feeling. Part 2 participants guardians will complete questionnaires about their child s AD. Part 1 participants will spray R mucosa on their arm twice per week for 6 weeks. Part 2 guardians will spray it on their child s arm twice per week for 16 weeks. Participants will have follow-up visits to repeat some baseline tests and review their memory aid: Part 1: Six weeks after the baseline visit Part 2: Four times over 16 weeks; then 2 or 3 times for 1 year Participants will be called or emailed to discuss how they are feeling: Part 1: About 30 days after their last visit Part 2: About every 10 days between visits

Conditions

Atopic Dermatitis

Keywords

Lyophilized Biotherapeutic, Microbiome, Probiotic; Commensal Gram-negative Bacteria; Staphylococcus Aureus; Transepidermal Water Loss; Allergic Diseases

Outcome Measures

Primary Outcomes (1)

• A 50% reduction in antecubital-specific SCORing Atopic Dermatitis (SCORAD) with no adverse events related to product use. Frequency of solicited adverse events, unsolicited adverse events, serious adverse events, and death.

  4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months

Secondary Outcomes (2)

• A 30% improvement in the quality of life as measured by the validated Children's Dermatology Life Quality Index (CDLQI)

  4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months

• A 30% improvement in the quality of life as measured by the validated Family Dermatology Life Quality Index (FDLQI)

  4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months

Study Arms (1)

1

EXPERIMENTAL

Vials of lyophilized R mucosa (10"3, 10"4, or 10"5 CFU)

Biological: Roseomonas mucosa

Interventions

Roseomonas mucosa BIOLOGICAL

R mucosa grown in Hank's balanced salt solution. Bacteria is washed, quantitated spectrophotometrically, suspended in 10%-15% sucrose, and lyophilized.

1

Eligibility Criteria

• Age: 3 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 16+ years
• SCORAD of at least 10
• Have a clinical diagnosis of AD with active involvement of the antecubital fossa
• Willing to allow storage of blood for future research
• No history of other skin disease
• Initiated or attempted standard of care therapy at least 6 months prior to enrollment
• Must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) when engaging in sexual activities that can result in pregnancy. The effects of CGN live biotherapy on the developing human fetus are unknown. Adequate contraception must be used consistently, beginning before the first dose and lasting for the duration of study participation. Participants of childbearing potential must have a negative pregnancy test result before they receive CGN live biotherapy. During the course of the study, if a participant becomes pregnant or suspects they are pregnant, then they should inform the study staff and their primary care physician immediately.
• Age 3-16 years
• SCORAD of at least 10
• Have a clinical diagnosis of AD with active involvement of the antecubital fossa
• Willing to allow storage of blood and bacterial swabs for future research
• Initiated or attempted standard of care therapy at least 6 months prior to enrollment
• Participants who have begun menstruating must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) when engaging in sexual activities that can result in pregnancy.

You may not qualify if:

• Presence of an indwelling venous or arterial catheter
• Individuals living with anyone with a diagnosed immunodeficiency, cardiac valvular disease, and/of indwelling catheter
• Precence of allergies to aimkacin, ciprofloxacin, gentamicin, levofloxacin, and tobramycin (which would preclude treatment of any unexpected infection)
• History of cardiac valvular disease
• Any history of grade 2 or higher neutropenia or leukopenia
• Clinical suspicion of immunodeficiency, liver disorder, kidney disorder, and/or HIV
• Pregnant or breastfeeding
• Any history of anti-TNF treatment
• Inability to demonstrate proper bacteria administration procedure despite coaching and training
• Use of fluoroquinolone or aminoglycoside antibiotics within 2 weeks of enrollment
• Any condition that, in the opinion of the investigator, contraindicates participation in this Study
• Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies or those evaluating the use of a licensed medication. Study staff should be notified of co-enrollment as it may require the approval of the investigator.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Boguniewicz M, Leung DY. Recent insights into atopic dermatitis and implications for management of infectious complications. J Allergy Clin Immunol. 2010 Jan;125(1):4-13; quiz 14-5. doi: 10.1016/j.jaci.2009.11.027.

  PMID: 20109729 BACKGROUND

• Myles IA, Williams KW, Reckhow JD, Jammeh ML, Pincus NB, Sastalla I, Saleem D, Stone KD, Datta SK. Transplantation of human skin microbiota in models of atopic dermatitis. JCI Insight. 2016 Jul 7;1(10):e86955. doi: 10.1172/jci.insight.86955.

  PMID: 27478874 BACKGROUND

• Bantz SK, Zhu Z, Zheng T. The Atopic March: Progression from Atopic Dermatitis to Allergic Rhinitis and Asthma. J Clin Cell Immunol. 2014 Apr;5(2):202. doi: 10.4172/2155-9899.1000202.

  PMID: 25419479 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Ian A Myles, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 12, 2017
• Study Start: April 20, 2017
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-10

Locations

US (1)