Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
|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: NCT03381625|
Recruitment Status : Active, not recruiting
First Posted : December 22, 2017
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Atopic Dermatitis||Drug: BMX-010 Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||January 2, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: BMX-010 0.03%
200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis.
Placebo Comparator: Placebo
100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.
- Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions [ Time Frame: 7-28 days ]Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions
- Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions [ Time Frame: 7-28 days ]Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions
- Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions [ Time Frame: 7-28 days ]Assessment of efficacy
- Peak Plasma Concentrations (Cmax) for BMX-010 [ Time Frame: 8 days ]
- Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010 [ Time Frame: 8 days ]
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): NCT03381625
|United States, California|
|Encino Research Center|
|Encino, California, United States, 91436|
|United States, Colorado|
|Denver, Colorado, United States, 80230|
|Colorado Skin Care|
|Englewood, Colorado, United States, 80113|
|AboutSkin Dermatology & DermSurgery|
|Greenwood Village, Colorado, United States, 80111|
|United States, Florida|
|Miami, Florida, United States, 33173|
|United States, Indiana|
|Dawes Fretzin Dermatology Group|
|Indianapolis, Indiana, United States, 46256|
|United States, New York|
|Juva Skin & Laser Center|
|New York, New York, United States, 10022|
|United States, South Carolina|
|Coastal Carolina Research Center|
|Mount Pleasant, South Carolina, United States, 29464|
|United States, Tennessee|
|Dermatology Associates of Nashville|
|Knoxville, Tennessee, United States, 37917|
|United States, Texas|
|Presicion Research Institute|
|Houston, Texas, United States, 77029|