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A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03304470
Recruitment Status : Completed
First Posted : October 9, 2017
Last Update Posted : March 20, 2018
Information provided by (Responsible Party):
UNION therapeutics

Brief Summary:
This is a Phase 2, 3-week, single-center, double-blind, randomized, two-arm, vehicle controlled study, with each individual receiving both active and vehicle treatment. Approximately 30 subjects with moderate atopic dermatitis will receive topically applied ATx201 CREAM 2% and matching vehicle once daily for 3 weeks (5 mg/cm2/day), without occlusion. ATx201 and vehicle will be applied on two separate target lesions of moderate atopic dermatitis (lesions of at least 3 × 3 cm, excluding the face, scalp, genitals, hands, and feet, ideally from the same anatomical location).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: ATx201 2% Cream Drug: ATx201 Cream Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Intraindividual, Vehicle-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Topically Applied ATx201 in Subjects With Moderate Atopic Dermatitis
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : March 5, 2018
Actual Study Completion Date : March 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: ATx201 2% CREAM Drug: ATx201 2% Cream
Anhydrous Cream

Placebo Comparator: ATx201 Cream Vehicle Drug: ATx201 Cream Vehicle
Anhydrous Cream

Primary Outcome Measures :
  1. Incidence of local and systemic treatment-emergent adverse events [ Time Frame: 34 days ]
    # of TEAEs

Secondary Outcome Measures :
  1. Change from baseline in lesional Total Sign Score at Days 8, 15, and 22. [ Time Frame: 22 Days ]
  2. Change from baseline in lesional Treatment Areas Assessment at Days 8, 15, and 22 [ Time Frame: 22 Days ]
  3. Change from baseline in skin barrier and biomarker levels at Day 22 [ Time Frame: Day 22 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • clinically confirmed diagnosis of active atopic dermatitis
  • at least a 6-month history of atopic dermatitis and had no significant flares in atopic dermatitis for at least 4 weeks before screening
  • ≥2 areas of atopic dermatitis (excluding face, scalp, genitals, hands, and feet) of at least 3 × 3 cm; with a lesional TSS of ≥5 at Day 1 for each treatment area

Exclusion Criteria:

  • breastfeeding, pregnant, or is planning to become pregnant during the study.
  • clinically infected atopic dermatitis
  • Fitzpatrick's Skin Phototype ≥5
  • Presence of any tattoos, scratches, open sores, excessive hair, or skin damages in the target lesion areas
  • known to have immune deficiency or is immunocompromised.
  • history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
  • major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
  • clinically significant medical condition or physical/laboratory/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
  • known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
  • used hydroxyzine or diphenhydramine within 1 week prior to Day 1.
  • used dupilumab within 12 weeks prior to Day 1.
  • received any nonbiological investigational product or device within 4 weeks prior to Day 1
  • used crisaborole and any other topical PDE-4 inhibitor within 4 weeks prior to Day 1.
  • used doxepin within 1 week prior to Day 1.
  • used topical products containing urea within 1 week prior to Day 1.
  • used nonurea-containing emollient anywhere on the body from 1 day before Day 1.
  • used systemic antibiotics or topical antibiotics on the treated areas within 2 weeks prior to Day 1.
  • used any topical medicated treatment for atopic dermatitis within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials, medical devices, and bleach baths.
  • used systemic treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to Day 1 (e.g., retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine, oral/injectable corticosteroids).
  • received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
  • excessive sun exposure, is planning a trip to a sunny climate, has received ultraviolet phototherapy, or has used tanning booths within 4 weeks prior to Day 1, or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products (excluding the treatment areas) and protective apparel are recommended when exposure cannot be avoided.
  • known or suspected allergy to ATx201 or any component of the investigational product.
  • known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
  • history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
  • history of hypertrophic scarring or keloid formation in scars or suture sites.
  • taking anticoagulant medication, such as heparin, low molecular weight-heparin, warfarin, or antiplatelets (nonsteroidal anti-inflammatory drugs and aspirin ≤81 mg will not be considered antiplatelets) within 2 weeks prior to Day 1, or has a contraindication to skin biopsies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304470

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Canada, Quebec
Innovaderm Research Inc
Montréal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
UNION therapeutics
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Study Director: Philippe Prokocimer Sponsor CMO
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Responsible Party: UNION therapeutics
ClinicalTrials.gov Identifier: NCT03304470    
Other Study ID Numbers: ATx201-003
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases