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Topical NanoDox® for Atopic Dermatitis

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nanodox 1% (doxycycline monohydrate hydrogel)
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • UF HealthStreet
  • UF Health Springhill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topical Administration of Study Drug

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Reduction in Growth of Skin Flora Including S.Aureus
(positive or negative), difference in number of growth (0 to 3+++)
Number of Participant With a Change in Investigator's Global Assessment (IGA) in Target Area
1 point reduction of IGA score in Target area pre-treatment compared to post treatment (v3)

Full Information

First Posted
September 1, 2016
Last Updated
March 16, 2020
Sponsor
University of Florida
Collaborators
Alchem Laboratories, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02910011
Brief Title
Topical NanoDox® for Atopic Dermatitis
Official Title
A Phase 2, Exploratory Study to Investigate Safety and Efficacy of Doxycycline Monohydrate Hydrogel (NANODOX® HYDROGEL 1%) In Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 18, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Alchem Laboratories, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Atopic Dermatitis (AD) is the most common inflammatory skin disease, affecting about 17% of children and 6% adults in the USA , . AD is characterized by skin barrier disruption, an aberrant adaptive immune response (i.e., Th2 polarized) to environmental allergens, susceptibility to cutaneous bacterial infections and intractable itch , . The intense pruritus and cutaneous infections contribute to the morbidity of AD and are major drivers of the reduced quality-of-life associated with this disease , . In the World Health Organization 2010 Global Burden of Disease survey, AD has ranked first among common skin diseases . So far, AD treatments have targeted inflammation with the widespread use of topical and more intermittent use of systemic corticosteroids. In summary, despite its high prevalence, effects on quality-of-life and economic burden - there are few effective treatments for AD. Doxycycline are tetracycline antibiotics broadly used systemically to treat inflammatory-dermatologic conditions. Several studies in human and animal models have shown doxycycline have anti-inflammatory and pro-healing properties, mainly by blocking tissue proteolytic activity. Doxycycline have been reported to nonselectively inhibit members of the metalloproteinases (MMP) superfamily [reviewed in , ]. In addition to this direct inhibitory activity, doxycycline indirectly prevents tryptic kallikreins activation by MMPs . Growing body of evidence suggests that the tetracycline might also directly downregulate Protease Activator receptor (PAR)-2 expression and function, which was also found to play a role in induction of local inflammatory mediators . Importantly, the doxycycline antimicrobial activity could lead to reduced Staphylococcus infection/colonization in AD skin, a known trigger of AD flares

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical Administration of Study Drug
Arm Type
Experimental
Arm Description
2.5 grams of Nanodox 1% (doxycycline monohydrate hydrogel) will be applied topically to an indicated lesion daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Nanodox 1% (doxycycline monohydrate hydrogel)
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Description
comparing dermatological scores of treated lesions vs non treated lesions and treated peri-lesional areas with non-treated non-lesional areas
Time Frame
up to 4 weeks of study drug use
Secondary Outcome Measure Information:
Title
Number of Participants With Reduction in Growth of Skin Flora Including S.Aureus
Description
(positive or negative), difference in number of growth (0 to 3+++)
Time Frame
up to 4 weeks of study drug use
Title
Number of Participant With a Change in Investigator's Global Assessment (IGA) in Target Area
Description
1 point reduction of IGA score in Target area pre-treatment compared to post treatment (v3)
Time Frame
4 weeks of topical therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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): 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) 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna De Benedetto
Organizational Affiliation
UF COM Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF HealthStreet
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
UF Health Springhill
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32653
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Topical NanoDox® for Atopic Dermatitis

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