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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304470
• Other study ID #: ATx201-003
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2017
• Last updated: March 19, 2018
• Start date: September 25, 2017
• Est. completion date: March 5, 2018

Study information

• Verified date: March 2018
• Source: AntibioTx A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• ATx201 2% Cream
Anhydrous Cream
• ATx201 Cream Vehicle
Anhydrous Cream

Locations

Country	Name	City	State
Canada	Innovaderm Research Inc	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
AntibioTx A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of local and systemic treatment-emergent adverse events	# of TEAEs	34 days
Secondary	Change from baseline in lesional Total Sign Score at Days 8, 15, and 22.		22 Days
Secondary	Change from baseline in lesional Treatment Areas Assessment at Days 8, 15, and 22		22 Days
Secondary	Change from baseline in skin barrier and biomarker levels at Day 22		Day 22