Topical NanoDox® for Atopic Dermatitis

NCT02910011 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB201601657 - A
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

This study will investigate the safety and clinical efficacy of a novel doxycycline topical formulation in subjects with Atopic Dermatitis (AD). The investigators hypothesize that daily application of the study drug in AD subjects will reduce severity of the disease, by reducing skin driven inflammation and restoring skin barrier function. The investigators will also monitor the anti-microbial activity of this product on AD skin, as colonization with Staph aureus is typically associated with disease severity.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  comparing dermatological scores of treated lesions vs non treated lesions and treated peri-lesional areas with non-treated non-lesional areas

  up to 4 weeks of study drug use

Secondary Outcomes (2)

• Number of Participants With Reduction in Growth of Skin Flora Including S.Aureus

  up to 4 weeks of study drug use

• Number of Participant With a Change in Investigator's Global Assessment (IGA) in Target Area

  4 weeks of topical therapy

Study Arms (1)

Topical Administration of Study Drug

EXPERIMENTAL

2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days

Drug: Nanodox 1% (doxycycline monohydrate hydrogel)

Interventions

Nanodox 1% (doxycycline monohydrate hydrogel) DRUG

Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner

Topical Administration of Study Drug

Eligibility Criteria

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

You may qualify if:

• Male or female, 18 through 65 years of age, inclusive who are generally healthy except for active atopic dermatitis diagnosed by the following criteria.
• Active Atopic Dermatitis: Subjects must have within the last 3 months according to medical records, patient account or by medical exam of the investigator:
• Pruritus
• Eczema (acute, subacute, chronic)
• Chronic or relapsing history
• Most subjects will have (seen in most cases, adding support to the diagnosis):
• Early age at onset
• Atopy
• Personal and/or family history
• Xerosis
• Subjects may have (these clinical associations help to suggest the diagnosis of AD but are too nonspecific for defining or detecting AD for research or epidemiological studies):
• Atypical vascular responses (e.g., facial pallor, white dermographism, delayed blanch response)
• Keratosis pilaris/hyperlinear palms/ichthyosis
• Ocular/periorbital changes
• Other regional findings (e.g., perioral changes/periauricular lesions)

You may not qualify if:

• As determined by the study doctor, a medical history that may interfere with study objectives (cancer, chronic illness)
• Known allergy to tetracycline
• Subjects with a systemic infection requiring a course of systemic antibiotics or antivirals within the last 2 weeks
• Unstable AD or any consistent requirement for systemic immune-modulant Rx (e.g. systemic steroids, phototherapy, Cyclosporine)
• History of use of biologic therapy (including intravenous immunoglobulin)
• Recent or anticipated concomitant use of systemic therapies that might alter the course of AD
• Recent or current participation in another research study
• Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study
• Subjects with a history of keloid formation
• History of lidocaine, epinephrine or Novocain allergy
• History of allergy to tape or other adhesive materials
• Hand eczema only (no body involvement).

Sponsors & Collaborators

• University of Florida: lead
• Alchem Laboratories, Inc: collaborator

Study Sites (2)

UF HealthStreet

Gainesville, Florida, 32608, United States

Location

UF Health Springhill

Gainesville, Florida, 32653, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

Results Point of Contact

• Title: Dr. Anna DeBenedetto
• Organization: University of Florida

adebenedetto@dermatology.ufl.edu

352 594 1500

Study Officials

• Anna De Benedetto

  UF COM Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 21, 2016
• Study Start: May 18, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: March 26, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)