Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381625
• Other study ID #: BMX-DERM-01
• Status: Completed
• Phase: Phase 2
• Start date: January 2, 2018
• Est. completion date: July 24, 2021

Study information

• Verified date: October 2021
• Source: BioMimetix JV, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, placebo-controlled Phase 2 trial consisting of up to 300 subjects with either psoriasis or atopic dermatitis. In this trial BMX-010 will be topically applied twice daily for up to 28 days.

Description:

This is a Phase 2, randomized, multicenter, placebo-controlled study sponsored by BioMimetix JV, LLC (BMX). It is a double-blind parallel cohort study designed to determine the safety and efficacy of BMX-010 (0.03%) relative to Placebo in subjects with atopic dermatitis and psoriasis.

Subjects will be queried regarding adverse events (AEs) and concomitant medication usage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: July 24, 2021
• Est. primary completion date: July 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of either atopic dermatitis or psoriasis with mild to moderate lesions involving 1% - 25% of total body surface area

• Candidate for topical treatment of atopic dermatitis or psoriasis

• Negative pregnancy test for females of childbearing potential

Exclusion Criteria:

• Systemic pharmacotherapy or phototherapy for treatment of atopic dermatitis or psoriasis

• Erythrodermic, guttate or generalized pustular psoriasis

• Treatment of systemic retinoids, corticosteroids or immunosuppressive agents within 4 weeks of baseline visit

• Treatment with high potency topical steroids, vitamin D analogs, keratolytics, coal tar, phototherapy, calcineurin inhibitors, or antihistamines within 2 weeks of baseline visit

• UV or Dead Sea therapy within 4 weeks of baseline visit

• Treatment with a biologic agent (monoclonal antibody) within 30 days or 5 times its circulating half-life (whichever is longer) prior to baseline visit

• Atopic dermatitis triggered by environmental allergen or irritant

• Contact dermatitis or drug-induced skin reactions

• Systemic or skin infection requiring antimicrobial therapy

• Systemic chemotherapy or radiotherapy within 4 weeks of baseline visit

• Immunocompromise of any cause

• Pregnancy, lactation or inadequate contraception

• Active drug or alcohol dependence

• Significant acute or chronic medical, neurological or psychiatric illness that would compromise subject's safety

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis

Intervention

Drug:
• BMX-010
Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis.
• Placebo
Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.

Locations

Country	Name	City	State
United States	Apex Dermatology	Denver	Colorado
United States	Encino Research Center	Encino	California
United States	Colorado Skin Care	Englewood	Colorado
United States	AboutSkin Dermatology & DermSurgery	Greenwood Village	Colorado
United States	Presicion Research Institute	Houston	Texas
United States	Dawes Fretzin Dermatology Group	Indianapolis	Indiana
United States	Dermatology Associates of Nashville	Knoxville	Tennessee
United States	Ciocca Dermatology	Miami	Florida
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Juva Skin & Laser Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
BioMimetix JV, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions	Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions	7-28 days
Primary	Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions	Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions	7-28 days
Primary	Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions	Assessment of efficacy	7-28 days
Secondary	Peak Plasma Concentrations (Cmax) for BMX-010		8 days
Secondary	Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010		8 days