Topical NanoDox® for Atopic Dermatitis

• Status: Completed
• Trial end date: 2018-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Alchem Laboratories, Inc
• Treatments: Doxycycline

Criteria

Inclusion Criteria:

• 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):

1. Atypical vascular responses (e.g., facial pallor, white dermographism, delayed blanch response)

2. Keratosis pilaris/hyperlinear palms/ichthyosis

3. Ocular/periorbital changes

4. Other regional findings (e.g., perioral changes/periauricular lesions)

5. Perifollicular accentuation/lichenification/prurigo lesions

• Moderate to Severe AD: clinical score based on Eczema Area and Severity Score (EASI) ≥ 10

• If receiving antihistamines, are on a stabilized dose, and expect to maintain this dose throughout the study

• All female subjects of childbearing potential must have a negative pregnancy test at screening visit and must be on an acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug.

Exclusion Criteria:

• 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).