Observer-Blinded Dose Escalating, Single Dose to Study Safety and Antimicrobial Efficacy of Gel vs. Placebo

NCT04192513 | Terminated Phase 2 DMC

• 1 other identifier: DBI-203
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison. The goal is to determine the safety and tolerability of DBI-001 Gel vs. Placebo in Adults with Atopic Dermatitis (AD).

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; S. aureus

Outcome Measures

Primary Outcomes (1)

• Change in Local Tolerability Based on Scale Listed

  Tolerability will be evaluated through assessment of local signs and symptoms. Scoring for burning, stinging, pruritus, erythema, edema, scabbing or crusting. : 0+ none (complete absence), 1=slight (slight), 2=moderate (definitely present), 3=severe (marked, intense).

  Baseline (Day 1) and 14

Secondary Outcomes (1)

• Change in S. aureus abundance

  14 Days

Other Outcomes (1)

• Atopic Dermatitis signs and symptoms

  14 Days

Study Arms (3)

Cohort 1 DBI-001 Gel and placebo

ACTIVE COMPARATOR

Cohort 1 DBI-001 Gel with low dose CFU's of J. lividum and placebo

Drug: J. lividum

Cohort 2 mid dose DBI-001 Gel and placebo

ACTIVE COMPARATOR

Cohort 2 DBI-001 Gel with mid dose CFU's of J. lividum and placebo

Drug: J. lividum

Cohort 3 high dose DBI-001 Gel and placebo

ACTIVE COMPARATOR

Cohort 3 DBI-001 Gel with high dose CFU's of J. lividum. Drug: J. lividum and placebo

Drug: J. lividum

Interventions

J. lividum DRUG

Investigational Product

Also known as: Janthinobacterium lividum

Cohort 1 DBI-001 Gel and placebo; Cohort 2 mid dose DBI-001 Gel and placebo; Cohort 3 high dose DBI-001 Gel and placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be included in the study:
• Ability to understand, agree to, and sign the study Informed Consent. If the patient is unable to provide consent for him/herself, the patient's legally authorized representative may provide written consent.
• A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information.
• Male or Female Subjects of any race 18 years of age and older.
• Physician diagnosed clinically stable Atopic Dermatitis according to the criteria of Hanifin and Rajka affecting ≤25% of total BSA with comparable bilateral antecubital or popliteal lesions. Each lesion must have an ADSI ≥6 with a difference between the lesions of ≤1. It will be in the opinion of the Investigator whether the lesions are clinically stable.
• Moderate to heavy growth of S. aureus based on culture at the time of screening.
• Willingness to discontinue use of other Atopic Dermatitis treatment for the duration of the study unless specifically permitted by the Investigator.
• Women of child-bearing potential must:
• Have negative urine pregnancy tests prior to study treatment to rule out pregnancy, and
• Use at least one method of birth control that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner for the duration of study participation.
• Willingness not to wash the antecubital lesions on both arms, or the popliteal lesions on both legs, with soap and water from the time of test article application at baseline visit until after the completion of the Day 2 visit.
• Allow digital photos of arms or legs to be taken and stored.

You may not qualify if:

• \. Women who are pregnant, planning a pregnancy, or breastfeeding or have a positive pregnancy test at the site.
• \. Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation.
• \. Known sensitivity to any of the components of the study medication. 5. Washout of 4 weeks for topical treatments used on the six designated sites, including but not limited to: antibacterial products, anti-inflammatories (e.g. corticosteroids, tacrolimus, Pimecrolimus). Other than the six sites on the arms or legs, topical mediations may be used before/during the duration of the study.
• \. Willing not to apply any prescription or over the counter topical product on the selected designated sites on arms or legs.
• \. Washout of 4 weeks for systemic treatments for AD, including but not limited to corticosteroids (oral or intramuscular injections), systemic immunomodulators or immunosuppressive (e.g., methotrexate, cyclosporine, hydroxychloroquine), antibiotics (oral or injected, if required to treat a medical condition short duration of oral antibiotics (≤10 days) are permitted after randomization).
• \. Spontaneously improving or rapidly deteriorating dermatitis of the antecubital fossa or popliteal fossa.
• \. Netherton's syndrome or other genodermatoses that result in defective epidermal barrier function.
• \. Washout of 4 weeks for bleach baths. 11. Washout of 4 weeks for phototherapy.

Sponsors & Collaborators

• DermBiont, Inc.: lead

Study Sites (1)

Instituto Dermatologico y Cirugia de Piel

Santo Domingo, Dominican Republic

Location

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

• Daisy Blanco, MD

  Instituto Dermatologico y Cirugia de Piel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is Observer Blinded
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, observer-blinded, vehicle controlled, single dose application, dose escalating bilateral comparison study of DBI-001 Gel vs. Placebo in the patients with Atopic Dermatitis (AD) affecting the antecubital areas and/or posterior popliteal areas. Subjects meeting the inclusion/exclusion criteria and having moderate to heavy growth of S. aureus from a sample collected at screening from an area of dermatitis on at least one arm or at least one leg will be enrolled into the study. Microbiological samples will be collected from all the designated sites on the arms or leg and all subjects will be treated with a single application of the assigned test articles applied by the unblinded treating investigator at the baseline visit.

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 10, 2019
• Study Start: May 20, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: June 18, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)